snapshot of stem cell companies in...

Snapshot of Stem Cell Companies in Australia

Snapshot of Stem Cell Companies in Australia

2016

Second Edition

Snapshot of Stem Cell Companies in Australia 2

About the NSW Stem Cell Network

The NSW Stem Cell Network is a professional community with an interest in all forms of stem cells.

The Network strategy is to work with the scientific, health and medical research communities, the higher education sector and business to promote growth and innovation to achieve positive outcomes for the people of NSW. Our work encompasses science, medicine, ethics, law, business and public awareness of stem cells.

Objectives of the NSW Stem Cell Network The Network, since its establishment in 2002, has worked towards:

Facilitating communication among members to promote the use of stem cells within an ethical framework;

Acting as a source of information on stem cells for the community and as a public advocate for them;

Promoting the development of resources to support the use of stem cells within New South Wales;

Enhancing the R&D and/or commercialisation potential of stem cells within New South Wales.

Contact us: www.stemcellnetwork.org.au

E: [email protected]

P: +61 (02) 9552 9981

About this Snapshot

A list of companies was formulated, largely compiled from information that was publicly available. A

questionnaire was sent out to relevant company representatives, and the information was compiled into this

Snapshot. Hence, the information contained within this Snapshot is up to date and relevant as of July 2016.

A draft was circulated back to the company representatives for approval before its publication and launch at

International Biofest 2016 (24-27th October, Melbourne).

The second edition of the Snapshot includes a more comprehensive list of companies and contains details of

clinical trials run by cell therapy companies (page 28).

Disclaimer:

The information contained in the Snapshot of Stem Cell Companies in Australia: November 2015 is intended solely for

general information. This publication must not be relied upon as a substitute for medical, investment or other

professional advice. You are encouraged to speak with the relevant contacts provided in the Snapshot for further

information. This Snapshot should not be read as reflecting the policies of the NSW Stem Cell Network, its Executive,

officers or members. Nor does the Snapshot represent an endorsement of the processes, procedures and technologies

described therein. The NSW Stem Cell Network does not accept any liability arising in any way from information

contained in this publication, including by reason of negligence for errors or omissions in the information. Only

companies that have agreed to be published in the Snapshot were included and, any liability resides with them.


Forward ……………………………………………………………………………………………………………………..……….…………… 4

Commercialisation Opportunities …………………………………………………………………………………..……….….…… 6

Companies Australian-based Stem Cell Companies……………………………………………………………………….…..…………… 8

Mesenchymal Lineage Adult Stem Cells

Mesoblast Ltd………………………..…………………………………………………………..…………………………..………..……… 9

Mesenchymal Stem Cells Cynata Therapeutics Ltd………………………………………………………………………………………..……………….…........ 10

Regeneus Ltd……………………………………………………………………………………………………………….………….……….. 11

Biobanking

CellCare……………………………………………………………………………………………………………………………………………. 12

Biotechnology

Calimmune Australia Pty Ltd………..…………………………………………………………………………………………........... 13

Genea Biocells Pty Ltd..………………………………..………………………………………………………………………………….. 14

Manufacturing and Medical Devices

Orthocell……………………………………………………………………………………………………………………………...………..... 15

Manufacturing

Cell Therapies Pty Ltd..………………………………..…………………………………………………………………………..………. 16

Medical Devices

Avita Medical Ltd……..………………………………..………………………………………….………………………..……..…........ 17

Overseas Stem Cell Companies with Branches in Australia ………………………………………...……….…...... 18

Cytomatrix……………………………………………………………………………………………………………………...……………….. 19

TerumoBCT Australia Pty Ltd…………………..………………………………..……….………………...………………..……….. 20

Laboratory Supply Companies

BD Biosciences…………………………………………………………………………………..…………………………………………….. 21

Bioscientific………………………………………………………………………………………………………………………………………. 21

Coherent Scientific ………………………………………………………………………………………………………………………….. 22

Eppendorf……………………………………………………………………………………………..………………...…………………...... 22

In Vitro Technologies Pty Ltd…………..………………………………………………………………………………………..……... 23

Lonza……………………………………………..………………………………………………………………………………………………… 23

Merck Millipore……………………………………………………………………………………………………………………………….. 24

Miltenyi Biotec and MACS Technology ……………………………………………………………………………………………. 24

PreproTech……………………………………………………………………………………………………………………………………… 25

Sapphire Bioscience.………………………………………………………………………………………………………………………… 25

Scientifix……………………………………………………………..………………………………………………………………………...... 26

STEMCELL Technologies Inc….………………………………………………..……………………………………………………….. 26

ThermoFisher ……………………………………………………………………………………………………………………………....... 27

VWR International…………………………………………………………………………………………………………………………… 27

List of clinical trials run by cell therapy companies…………………………………………………………………………… 28


Forward

Great progress has been made since the first attempts to treat diseases using stem cells over the past 50 years, with blood

disorders being the lead disease treated. In Australia, there are more than 150 people with acute leukaemia treated

annually with haemopoietic stem cells. In this Century, the use of stem cells for other disorders is being contemplated

and trialled. These include multiple sclerosis, diabetes, macular degeneration, spinal cord lesions and cancer. Despite

the innovative advances in this field, the full potential of cell therapies is yet to be realized.

The NSW Stem Cell Network has nurtured the stem cell community for the past 14 years to grow and advance stem cell

research and development. The Network has over 500 members around Australia including clinicians, researchers, policy

developers, members of Government, lawyers, ethicists, students, patients and companies, who are all passionate

advocates working together for the growth of the stem cell industry. With this report, our intention is to elevate stem cell

business in Australia to the next level.

In the snapshot, we profile current stem cell companies, some of whom are licensed by the TGA, and are carrying out

ethically approved controlled stem cell clinical trials registered with an appropriate entity. Details of Australian clinical

trials run by stem cell therapy companies can be found in page 28 of this document.

The growing number of stem cell trials registered in Australia and worldwide reflect recent efforts to expand the use of

cell therapies to a broader range of conditions. However, maximum research and development potential can only be

achieved with the provision of substantial support from government bodies and the private sector.

Stem cell research and development is particularly flourishing in countries where there is plenty of investment from both

Government and the private sector. In the US, Singapore, Israel and Canada, there is a solid business model for

progressing innovative stem cell research. Meanwhile, changes in regenerative medicine regulations in Japan have

attracted great international interest for the Japanese market, especially due to accelerated commercialisation

opportunities.

In Australia, the commercialisation of Stem Cells has been an enormous challenge over the past ten years for a number of

reasons. The perception of being a risky investment in biotechnology stem cell companies, lack of strong Government

funding in stem cells and the small pool of specialist stem cell businessman that sit on company boards and mentor the

growth in stem cell companies, are just a few of the hurdles.

A number of companies have chosen to seek investment from overseas organisations to assist their growth in Australia,

whilst others have secured a foot of their business overseas to create a channel for investment. Some companies are

desperately seeking partnerships with pharmaceutical companies, with minimal success.

The companies progressing with autologous stem cell products already on the market for patients with sports or other

injuries have come up against other challenges relating to a relatively unregulated marketplace including scrutiny from

Government regulatory bodies.

According to a number of industry experts, there is a need for stem cell organisations including companies to come

together under one banner with a united voice. Importantly, the stem cell group needs to have influential advocates who

can lead the charge in stem cells.

When the Hon Jillian Skinner, NSW Minister for Health, opened the 23rd of the NSW Stem Cell Network, she advised her strong support for the translation of stem cell research from the lab to the clinic. Well known businessman, Frank Lowy invested over $5 million into stem cell research. More advocates like this are needed in Australia to drive the business of stem cells.

The Regulations

In pursuing the goal of developing stem cell therapies, there is the need to obtain regulatory approval for both

development of the product, and for conducting clinical trials to test safety and efficacy.

The Therapeutics Goods Administration (TGA) provides guidance and advice concerning all of the above, with the

regulatory framework being that for biologicals. It is advantageous for discussions to be held with relevant officers of the

TGA prior to proceeding with clinical trials, to help circumvent problems that might otherwise arise.


The conducting of clinical trials with stem cells requires approval from a duly constituted Human Research Ethics

Committee. This will require reasonable pre-clinical evidence that they might work in humans, and that the cells are well

characterized, and free of microbiological contamination. Good Clinical Practice is needed.

In addition, before the Trial can proceed, acknowledgement by the TGA that the Trial is being conducted (Clinical Trial

Notification), or a more thorough assessment of it by the TGA (Clinical Trial Exemption), is needed. If the use of the stem

cells has been approved by the Regulatory Body of another country, especially the Food and Drug Administration of the

USA, it is probable that the TGA will support its use in a trial in Australia.

Registration of stem cells as a treatment for a medical condition requires them to have been tested in several phases,

initially for safety (phase 1), then efficacy in a relatively small study (phase 2), and finally at multiple sites in a larger

cohort of people (phase 3). Evidence that the therapy will work usually requires it to be tested against a control group,

to determine the placebo effect, which can be quite large. Registration of the product occurs after phase 3 trials.

Sometimes, stem cells will be placed in a device before being used. This might be a scaffold to allow the stem cells to

attach and proliferate more readily, or an immunoisolation system to protect them from the recipients’ immune system.

Approval for the use of such devises also comes under the biologics framework.

Unregulated by the TGA as detailed in the Excluded Goods Order is the possibility for a clinician to obtain cells from his/

her patient, process them, and re-administer them to that person, e.g., for the treatment of sports injuries. Some

members of the autologous stem cell industry have written a Code of Conduct to encourage its self-regulation, and the

TGA is currently examining what form of regulation would best serve Australia in this contentious area.

The NSW Stem Cell Network has committed to compiling this list of stem cell companies as the next step forward to drive the development of the stem cell industry in Australia, hopefully providing insight around where Australia is at right now. Combining this information with the Snapshot of Stem Cell Research in Australia published in 2014 by the

National Stem Cell Foundation of Australia we believe will create a solid landscape of stem cells R & D in our country . Professor Bernie Tuch Dr Daniella Goldberg

NSW Stem Cell Network NSW Stem Cell Network

Director Executive

Dr Goldberg is a Director of the public relations firm Gene Genie Media; Professor Tuch is an endocrinologist and non-

executive Director of the biotechnology company Living Cell Technologies Ltd.


Commercialisation Opportunities

While stem cells hold incredible potential and opportunities, it is a field that also presents many challenges.

Being a bespoke technology customised for each patient, the clinical development program is expensive and

economies of scale are smaller. Attracting investors has sometimes been difficult due to the risks

outweighing the benefits, and the high cost of producing the product. Cost issues are compounded by the

reliance on materials from other industries.

Speaking at AusBiotech’s Regenerative Medicine Symposium 2015, Carryn King, Novartis’s New Products

Manager Oncology/ Haematology, said that big pharma haven’t been in the cellular therapies space for long

and that new approaches are required. The path and timeline for funding are challenging, and highly

dependant on the offering. There is complexity across all functions – manufacturing, consumer market access

(such as how should patients be prioritised and scheduled) and commercialisation model considerations.

There are also greater education needs for investors and patients, and companies are learning what

questions to ask.

Speaking at the same Symposium, Paul Anderson, Managing Director of Orthocell said the challenges are

ongoing on a daily basis: “There are no risk-free avenues available, work out what you can and can’t control”.

He said companies need to ask the following questions:

Is there a genuine market need?

How internationally transferable is it?

Will it cost more to make than sell?

Can we protect IP?

Do we have the money? Can we raise it?

“Investors need to understand your business. There’s a lot of peripheral noise in the stem cell space, we need

to show who’s doing it properly.”

One recent success story is Australian biotech Mesoblast, the shares of which rose by 22% in April 2015 after

US-based biotech giant Celgene Corporation invested $58.5 million to buy about 4.7% of Mesoblast and get

access to its anti-cancer drugs. Celgene will also get a six-month right of first refusal on Mesoblast’s

proprietary adult stem cell product candidates for the prevention and treatment of acute graft versus host

disease, certain cancers, inflammatory bowel diseases and organ transplant rejection (this was later extended

for another six months).

In a Market Insight report for the September 2015 edition of Australasian BioTechnology, Rhenu Bhuller of

Frost and Sullivan wrote: “The Asia-Pacific stem cell market was valued at US$7.10 billion in 2014 and is

projected to increase to US$18.71 billion by 2018 growing at a compound annual growth rate of 27.3% for

the period. This growth is a result of the increasing regulatory support regarding stem cell research,

advancements in regenerative medicine and the opportunities arising from stem cell therapies. These

opportunities include contract research outsourcing and an increase in the patient population with

neurological and other chronic conditions in the region. Japan, Singapore and South Korea are the

frontrunners and set to dominate the Asia Pacific stem cell market in the coming years.

“Australia has started to develop critical infrastructure needed for regenerative medicine research and there

have been some achievements such as the success of companies like Mesoblast as well as the $153 million

Australian Regenerative Medicine Institute (ARMI) at the Monash University Clayton campus. Australia is also

starting to gain ground internally with partnerships like the ARMI-MDI Biological Laboratory one which will

enable knowledge sharing and hopefully accelerate discoveries in areas such as heart disease, autoimmune

diseases and musculoskeletal disorders.”


“However, there are still only a handful of companies with products in commercialisation. One of the barriers

is the cost and on a more practical level, the supply chain that will enable larger access to such therapies.

Whilst the Asia Pacific region holds high potential for the commercialisation of regenerative medicine, having

to transfer material from Australia to Asia and vice versa is a costly exercise. However, opportunities are

present and results would best be attained through partnerships between Australian researchers and

companies with those in Asia, for example Japan or Korea, which could be a combination of consultative

services and lab or on-site production facilities,” wrote Ms Bhuller.

The CRC for Cell Therapy Manufacturing, based at University of South Australia, is a project-based global

network established to help facilitate the cost-effective manufacture and rapid translation of cell therapies

into clinical practice.

Dr Tim Oldham, Chief Executive Officer, Cell Therapies Pty Ltd, writing in the September 2015 edition of

Australasian Biotechnology, stated: “A whole new manufacturing and supply industry must be created if

thousands of patients are to benefit from these breakthrough therapies. Traditional pharmaceuticals are

inert, largely temperature stable and can be manufactured centrally in batches of thousands or millions of

doses to sit on a pharmacy shelf until needed. Cellular therapies are patient specific, living products that are

inherently fragile, have very short shelf-lives unless stored in liquid nitrogen and are highly variable. A clinical

prescription initiates and just-in-time, time critical production process with each batch producing a single

product for one patient. Today these processes are very manual and very expensive.”

“An advanced manufacturing eco-system is developing around these new therapies. Cell Therapies already

collaborates with Invetech Ltd in Melbourne for process automation, the CRC for Cell Therapy Manufacturing

in Adelaide for cost reducing processes and Peter Mac for optimising cell collection by apheresis. Australia

has a genuine opportunity to be more than a local manufacturing hub – it can also become an advanced

manufacturing leader in this field.”

Australia faces the challenge of needing a regulatory approach that enables Australian companies to be part

of this exciting medical frontier, but also addresses the safety and quality concerns. Structural weaknesses in

regulation in some other countries have seen some patients travel overseas to access “stem cell therapies”

the safety and efficacy have yet to be established . To realise the clinical promise of stem cells, companies

must address the challenges of how to reduce risk, how to increase cost-effectiveness and eventually how to

deal with explosive demand.

R & D Tax Incentive and other tax reform

The 2011 introduction of the R&D Tax Incentive was a momentous point for Australian innovation. The

Incentive is actively attracting companies from around the world to bring their R&D to Australia and

supporting medical R&D via small innovation companies. Start-up innovation companies, especially

biotechnology companies trading in loss, are the biggest beneficiaries from the Tax Incentive’s 43.5%

refundable component. The legislation also benefits large innovative companies by reducing the cost of

conducting eligible R&D activities in Australia, making Australia a more competitive location for conducting

biomedical and pharmaceutical R&D and clinical trials.

Glenn Cross, CEO, AusBiotech

AusBiotech Investment offers a series of state-based, national and international investor events as a platform

to showcase Australian biotech companies to potential partners and investors. The annual Australia Biotech

Invest and Asia Biotech Invest are the keystone events. More details can be found at www.ausbiotech.org/

investment

http://www.ausbiotech.org/investment

http://www.ausbiotech.org/investment


Australian-based

Stem Cell Companies


Mesoblast Limited is a global leader in cellular medicines. The Company has leveraged its proprietary

technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to

establish a broad portfolio of late-stage product candidates.

Mesoblast Limited is committed to delivering innovative cellular medicines. Its allogeneic, ‘off-the-shelf’ cell product candidates target significantly advanced stages of diseases where there are high unmet medical needs. Mesoblast’s portfolio of mesenchymal lineage adult stem cell-derived product candidates each has its own distinct technical characteristics, target indications, individual reimbursement strategy, separate commercialization potential, and unique partnering opportunities.

PIPELINE

Mesoblast has established what it believes is the industry’s most clinically advanced and diverse portfolio of cellular medicines. There are five programs, two of which are partnered, in active Phase 3 clinical studies or Phase 3-ready, and four programs in Phase 2. All of the Company’s clinical programs target significant, under-served therapeutic areas including cardiac diseases, immune-mediated and inflammatory conditions, oncology and hematology diseases, and spine orthopedic disorders.

LATEST NEWS

Mesoblast licensee in Japan has received Japanese Government regulatory approval for its mesenchymal stem cell-based product, which is the first allogeneic regenerative medicine product to receive full approval in Japan. Mesoblast believes it is well positioned to have the first industrially manufactured allogeneic stem cell product

approved in the United States.

CEO: Professor Silviu Itescu

Established in Australia in 2004

ABN: 68 109 431 870

Status: Public

www.mesoblast.com

CONTACT

Julie Meldrum | Global Head of Corporate Communications

P: +61 (0)3 9639 6036


Mesenchymal Lineage Adult Stem Cells (MLCs) comprising Mesenchymal Precursor

Cells (MPCs) and culture-expanded Mesenchymal Stem Cells (MSCs)

mailto:[email protected]


Mesenchymal Stem Cells

Cynata Therapeutics Ltd is developing a proprietary therapeutic stem cell platform technology, Cymerus™, which

arose from the University of Wisconsin-Madison, a world leader in stem cell research. Cymerus™ addresses a

critical shortcoming in existing methods of production of mesenchymal stem cells (MSCs) for therapeutic use: the

ability to achieve economic manufacture at commercial scale

Limitations in conventional methods of MSC production include the dependence upon donors, the variability between

donors, the relative scarcity of MSCs in adult tissue, and the low proliferative capacity of adult stem cells compared to

pluripotent stem cells. Cynata believes that the Cymerus™ technology may address all of these issues, and the

Company's activities in relation to the Cymerus™ technology are aimed at achieving that. This uniquely places Cynata

to capitalise on the flourishing field of stem cell therapeutics. The Company has been covered in highly favourable

equity research analyses published by Baillieu Holst, BBY, SeeThru Equity, Rodman & Renshaw and Shaw & Partners.

PIPELINE There has been extensive interest in the development of MSCs as therapeutic agents, in light of their ability to secrete

bioactive molecules such as cytokines, chemokines, and growth factors, in addition to their immunosuppressive and

immunoregulatory properties. There are currently over 300 active clinical trials of MSCs, covering an extremely wide

range of therapeutic indications, including haematological, cardiovascular, orthopaedic, gastrointestinal and

autoimmune disorders, among others. Cynata is currently planning a Phase 1 clinical study in graft-versus-host

disease (GvHD) for the Company’s lead MSC product, CYP-001. Approval for the trial has been granted by the UK

Medicines and Healthcare products Regulatory Agency (MHRA) and it is expected to commence late in 2016. It is

envisaged that this study will serve a clinical proof of concept, and a basis for further development in numerous other

indications, such as those in which MSCs from other sources have previously been investigated. Cynata is also

investigating the potential of modified MSCs to treat other conditions, including cancer and announced in 2016 a

partnership with German company Apceth to investigate engineered MSCs in cancer.

LATEST NEWS Cynata has successfully completed a proof-of-concept studies with its Cymerus™ MSC product in models of critical

limb ischaemia, asthma and in GvHD , in which efficacy was clearly demonstrated, and further proof of concept

studies in models of idiopathic pulmonary fibrosis are ongoing. The company has also completed technology transfer

and scale-up of the Cymerus™ manufacturing process to a GMP-compliant manufacturing facility. Cynata is also

conducting additional programs, one in cardiovascular disease with the University of Sydney and another to develop

modified MSCs to treat cancer, in collaboration with Massachusetts General Hospital/Harvard Medical School. The

Company has also announced a developing strategic alliance with FUJIFILM, a major participant in the regenerative

medicine sector.

CEO: Dr Ross Macdonald


ABN: 98 104 037 372

Status: Private

www.cynata.com

CONTACT

Dr Ross Macdonald

P: +61 (0) 412 119343




Mesenchymal Stem Cells

Regeneus Ltd is an ASX-listed clinical stage regenerative medicine company developing a portfolio

of innovative cellular therapies for the human and animal health markets

Regeneus’ clinical focus is on osteoarthritis (OA), cancer, inflammatory skin conditions and wound care.

The company’s product pipeline is underpinned by proprietary stem cell and immunotherapy technologies comprising:

allogeneic off-the-shelf adipose-derived mesenchymal stem cells (MSCs) for OA and other inflammatory conditions (Progenza for humans and CryoShot for animals)

allogeneic off-the-shelf bioactive secretions from adipose-derived MSCs for inflammatory skin conditions and wound care (for humans only)

autologous cancer immunotherapy that uses the patient’s tumour cells and a bacterial adjuvant for immune recognition (RGSH4K for humans and Kvax for animals)

MSCs respond to the local disease environment and secrete a diverse variety of bioactive factors including cytokines and growth factors that are responsible for reducing inflammation, promoting tissue repair and reducing scarring.

PIPELINE

The company is conducting two Phase 1 human trials: the STEP trial using Progenza to treat OA has completed recruitment and the pre-specified review of patient safety data showed no safety concerns. The 12 month post-treatment follow-up will be completed in Q3 FY17; the cancer vaccine trial (ACTIVATE) has commenced and enrolment should be completed in H2 FY17. The company will be conducting clinical studies for its secretions technology for topical applications.

LATEST NEWS

Regeneus is well advanced in discussions for licensing its Progenza technology for manufacture, development and commercialization in Japan. Japan has become an active market for partnering of stem cell technologies and therapies following the introduction in 2014 of regulations that provide an accelerated pathway to bring new cell therapies to market.

CEO: John Martin

Established in Sydney, Australia in 2007

ABN 13 127 035 358

Status: Public (ASX: RGS)

www.regeneus.com.au

CONTACT

Sandra McIntosh | Investor Relations

P: +61 2 9499 8010


Biobanking

Cell Care is Australia’s largest and most experienced cord blood and tissue stem cell bank. We collect process and store umbilical cord blood and tissue to provide potential medical treatment options for Australian families. Cell Care is Australia’s largest and most experienced cord blood and tissue bank. Cell Care has recently acquired Insception Lifebank, Canada’s largest private cord blood & tissue bank. The combined entity creates one of the world’s top 10 companies in the sector. Together, we store over 100,000 client samples and establish a global platform to expand its clinical trial initiatives into North America that may potentially include cord blood investigations in cerebral palsy and type-1 diabetes.. Cell Care operates according to the highest level of quality management systems and is regulated for storage and release by the Therapeutic Goods Administration. All of Cell Care’s processes are structured according to, and aligned with the Australian code of Good Manufacturing Practice (cGMP) and the Foundation of Accredited Cellular Therapies standard (FACT/ Netcord). Our facility is located in Melbourne. Whilst we collect cord blood from virtually all maternity hospitals in Australia, the main challenge for the business is to drive awareness and uptake of cord blood banking with only 1-2% of all births in Australia storing privately. We invest in driving market awareness through multiple consumer and health care professional channels. We manage our own national network of up to 100 cord blood collectors and own the entire value chain from marketing to collections, laboratory processing, storage and release (transport excluded). We are experiencing strong growth and have high levels of expertise across all areas of the business. CLINICAL TRIAL NEWS Our research investment program supports pre-clinical and clinical local Australian research investigating methods to improve clinical outcomes for approved and potential new indications for cord blood therapy. In June 2015 Cell Care received national TV and print news coverage when a four-year Perth girl became the first person worldwide to receive her own cord blood (stored at Cell Care since birth) in a clinical trial investigating the safety and efficacy of cord blood to prevent or delay the onset of type 1 diabetes. This study, being run by Sydney’s Kids Research Institute at the Children’s Hospital Westmead is funded by Cell Care and aims to screen 400-600 high risk type 1 diabetes children with the aim of 20 reinfusions in the next 3 years. LATEST NEWS Cell Care in partnership with the Cerebral Palsy Alliance, is funding a second clinical trial investigating the potential of sibling cord blood to treat children with cerebral palsy. The study, sponsored by the Murdoch Childrens Research Institute in Melbourne, received governance and ethics approval in August 2016 from the Royal Children’s Hospital and is currently screening up to 48 children with the aim of infusing 12 children with Cerebral Palsy with fully matched sibling cord blood. This study is Australia’s first cell therapy clinical trial for cerebral palsy, and will add valuable insight to the already growing data investigating the safety and efficacy of cord blood in this setting, and further explores the possibility that sibling (related) cord blood delivers better outcomes than non-related donors. The above clinical study is being extended by collaboration between Cell Care and The Ritchie Centre, at the Hudson Institute of Medical Research exploring the expansion of neurotrophic factors from umbilical cord blood cells for the treatment of neurological disorders. This study received funding from The Science and Industry Endowment Fund (SIEF) in June 2016 for a three year period.

CEO: Brent Dennison


ABN: 35 110 312 537

Status: Private

www.cellcare.com.au

CONTACT

Brent Dennison

+61 (03) 8551 0200

[email protected]


CEO: Mr Louis Breton

Established in Australia

as Calimmune Australia Pty Ltd in 2009

ABN: 86 134 900 397

Status: Private

www.calimmune.com

CONTACT

Hailee Jones | Administrative Manager

P: +61 (02) 8382 4921


Biotechnology

Calimmune is accelerating the promise of gene therapy to liberate patients from chronic

and currently incurable diseases. To achieve our ambitious goal, we have built a suite of

technologies to advance the delivery, manufacturing, and overall efficiency of these life-

changing medicines. Calimmune’s lead development programs are novel ex-vivo gene

therapies for hematologic diseases.


Biotechnology

Genea Biocells is a neuromuscular disease-focused discovery stage company using proprietary human pluripo-

tent stem cell technologies. Genea Biocells also provides contract research services to pharma and supplies re-

agents to strategic academic collaborators to expand their capabilities and further validate their technologies.

Genea Biocells has one of the world’s largest banks of pluripotent human embryonic stem cells and developed

the world’s first consistent, scalable and high-yield differentiation process for functional skeletal muscle cells.

Genea Biocells is based in San Diego, California and is part of the Australian Genea group, a public, unlisted

company that has been operating world leading IVF clinics since 1985. The company has been supplying com-

mercial stem cell solutions for 10 years, drawing on an almost 30 year research heritage within Genea.

PIPELINE

Genea Biocells’ lead programs are (1) small molecule modulators of FSH muscular dystrophy, one of the most

common genetic muscle disorders, and (2) stem cell-derived satellite cells for cell therapy.

LATEST NEWS

Californian/Australian drug discovery company Genea Biocells has demonstrated and described the world’s

first human stem cell-based cellular model for a muscular dystrophy that is suitable for high-throughput

screening and drug development. In research published in Stem Cells Translational Medicine, scientists from

Genea Biocells analyzed in detail cellular and molecular aspects of facioscapulohumeral muscular dystrophy

(FSHD) during myogenic development and in myotube cultures by comparing muscle cells generated from five

FSHD-affected and four normal control stem cell lines. Facioscapulohumeral Dystrophy (FSHD) is an inheritable

muscle disease affecting approximately 1 in 8,000 people. There is no cure or treatment strategy for patients

with FSHD. The findings highlight Genea Biocells’ efficient and highly scalable monolayer system to differenti-

ate human pluripotent stem cells into skeletal muscle cells and demonstrate disease-specific phenotypes in

muscle derived from both human embryonic and induced pluripotent stem cells affected with FSHD.

CEO: Dr Tomas Stojanov


ABN: 68 074 369 038

Status: Private

www.geneabiocells.com

CONTACT

Dr Uli Schmidt | General Manager

P: +61 (02) 8484 6510


http://www.geneabiocells.com


Orthocell Ltd is an Australian regenerative medicine company dedicated to the development and commercialisation of

an important new class of autologous cellular therapies and collagen scaffolds for the treatment of human tendons,

ligaments and soft tissue defects.

Development to date has focused on two main products: ‘Autologous Tenocyte Implantation’ (“ATI”) and the

biological reconstruction scaffold ‘Celgro™’. Orthocell has achieved significant development milestones to date

including a licence from the Therapeutic Goods Administration (TGA) to manufacture human tissue in its wholly-

owned, state of the art facility. This facility has enabled the company to commercialise ATI and manufacture its

biological reconstructive scaffold Celgro™. Orthocell’s technologies have now been substantially de-risked; its target

markets are large and growing; its products and procedures are regarded by key opinion leaders as being superior to

existing therapies

PIPELINE

Orthocell is focused on the 3 key areas of regenerative medicine in the musculoskeletal space. Cells, growth factors,

and scaffolds form the core of Orthocell’s pipeline opportunities with strong preclinical data supporting the concept

of tissue specific growth factor production, a solid pipeline of scaffold opportunities across a multiple specialities and

applications and continued work on ligament and tendon replacement technologies incorporating both cellular and

scaffold aspects.

LATEST NEWS

The Company partnered in the receipt of an Australian Research Council (ARC) grant of $430,000 to further

investigate tendon tissue and develop novel therapies such as the laboratory fabricated tendon project announced

by Orthocell in November 2014.

The announcement of the Company’s innovative cell factory derived proteins pipeline product was further

validated following the publication of data from a collaborative research project involving centres in Sweden,

Australia and India. The paper was published in the leading scientific publication Journal of Tissue Engineering and

Regenerative Medicine and provides peer reviewed support for a new approach to regeneration of damaged

cartilage within joints which is highly complementary to Orthocell’s current Ortho-ACITM cartilage repair product;

The Company held its inaugural user group meeting in Sydney. Attendees included 40 leading orthopaedic

surgeons, sports physicians, radiologists, physiotherapists and pain clinicians from Australia and New Zealand. The

meeting brought together some of Australia’s leading doctors to discuss their experiences with The positive

experiences and clinical outcomes presented further demonstrated that Ortho-ATITM technology is a safe and

effective treatment for degenerate tendons; and

The presentation by Orthocell’s collaborators of its successful ‘cell factory’ data at the European Bone and Joint

Infection Society in Estoril Portugal September 2015. The data was generated as a result successful collaboration

with institutes in Sweden, Australia, Denmark, India and UK and has supported the role of growth factors and

extracellular matrix proteins which were derived by the researchers from bone cells cultivated in a cell factory, to

be combined with scaffolds, to regenerate serious bone defects .

CEO: Paul Anderson


ABN: 57 118 897 135

Status: Public

www.orthocell.com.au

CONTACT

Paul Anderson

P: +61 411 861 626

[email protected]

Manufacturing and

Medical Devices


Cell Therapies is leading in cGMP manufacture and distribution of cellular therapies in Asia Pacific. We provide the essential deployment infrastructure for the safe, reliable and scalable delivery of cellular therapies into clinical

trials and for therapeutic use.

Cell Therapies is leading in cGMP manufacture and distribution of cellular therapies in Asia Pacific. We provide the essential deployment infrastructure for the safe, reliable and scalable delivery of cellular therapies into clini-cal trials and for therapeutic use in a region of more than 750 million people. Playing a pivotal role in the cellular therapy value chain, we are poised to deliver essential capability to, and capture significant value from, a sector now delivering transformative health outcomes. For over a decade, Cell Therapies has operated TGA regulated cell processing facilities from our home at Peter MacCallum Cancer Institute and made these facilities available on a fee-for-service basis to some of the world’s leading cellular therapies companies. We have successfully helped develop products and processes that are compliant with global regulatory and cGMP requirements and have successfully integrated with global manufacturing networks. This capability is in short supply as cellular ther-apy products reach maturity.

Cell Therapies is expanding its deployment network with a strategic alliance with PharmaBio in Japan. We have also added an apheresis site management service line to provide control over this critical starting material.

We can now offer a single gateway to Asia to customers at translational research through commercial launch scale.

PIPELINE

Cell Therapies has broad experience manufacturing and delivering a wide range of cellular therapy products, gen-erated from a wide range of tissue types, with a wide range of cell processing techniques and in a wide range of indications. Our expertise is deepest in autologous therapies in the areas of gene therapies, gene-modified immu-notherapies (eg CAR-T), immunotherapies (eg DC vaccines), regenerative medicine and apheresis.

LATEST NEWS

Recent highlights at Cell Therapies include:

Entering a strategic alliance with PharmaBio of Japan to create a joint business development collaboration under a harmonised quality system

Opening our new 10 clean room GMP cell processing facility at the new home of Peter Mac, the VCCC Building in Melbourne's Parkville precinct. This doubles our capacity in Melbourne and is the template for a new facility PharmaBio is constructing in Japan.

CEO: Tim Oldham, PhD


ABN: 15 100 285 916

Status: Private

www.celltherapies.com.au

CONTACT

Cell Therapies Pty Ltd

P: +61 3 8559 7310


Manufacturing


Medical Devices

Avita Medical develops and distributes regenerative products for the treatment of a broad range of burns,

wounds, scars and skin defects. Avita’s patented and proprietary collection and application technology provides

innovative treatment solutions derived from a patient’s own skin.

Avita’s lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic

procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the

United States, ReCell® is an investigational device limited by federal law to investigational use.

ABOUT RECELL®, REGENERCELL®. RENOVACELL®, AND RES™

ReCell® is Avita Medical’s unique proprietary technology that enables a clinician to rapidly create, at point of care in

approximately 30 minutes, Regenerative Epithelial Suspension (RES™) using a small sample of the patient’s skin. RES™ is an

autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin. RES™

has a broad range of applications and can be used to restart healing in unresponsive wounds, to repair burns using less

donor skin yet with improved functional and aesthetic outcomes, and to restore pigmentation and improve cosmesis of

damaged skin.

PIPELINE

Product derivatives to meet new clinical indications, including chronic wounds such as Diabetic Foot Ulcers and Venous Leg

Ulcers.

LATEST NEWS Business

Awarded a contract with BARDA for up to US$53.9m

Received CE Mark for ReGenerCell and ReNovaCell – product derivatives

Entered into a research partnership with University of Huddersfield

Received patent validation in 11 European countries

International rollout of proposition with distributor appointments in 12 territories, including China

Strengthened Board and management positions to accelerate commercialisation

A data-driven commercial execution strategy, with clear milestones, to make the approach mainstream

Value creation is the main commercial focus of the management team Clinical

Publication in the Journal of Cranio-Maxillo-Facial Surgery of results from a series of cases using ReCell® show clinically significant improvements in aesthetic outcomes

First patient treated in investigator-initiated trauma wound trial at Walter Reed National Military Medical Center

FDA-approval of expanded Compassionate Use Investigational Device Exemption (IDE) program for ReCell® to continue clinical evaluation on twice as many patients as originally permitted

Presentation of three academic papers at the 16th European Burns Association Congress that further demonstrate ReCell®’s effectiveness

Extensive data package that includes more than 60 publications

Recent RCTs in chronic wounds and repigmentation show significance

FDA burns trial fully recruited, and on track for PMA pathway submission: approval expected Q3 2017

Randomized, multi-centre venous

CEO: Adam Kelliher


ABN: 28 058 466 523

Status: Public

www.avitamedical.com

CONTACT

Lorraine Glover| General Manager, Asia Pacific

P: +61(08) 9474 7738



Overseas Stem Cell Companies

with branches in Australia


Biotechnology

Cytomatrix was formed in 2007 to develop a series of technologies licensed in from Cordlife Ltd (a foundation

shareholder), Barwon Health and Deakin University. This led, in 2014, to the formation of HeiQ Australia, a Joint

Venture with Swiss chemical company HeiQ AG, to develop a world leading technology for the manufacture of short

nanofibres, and in 2015 to the formation of Nohla Therapeutics Inc, a US-based company that has licensed in seven

patent families in the field of haematopoietic stem cell expansion from the Fred Hutchinson Cancer Research Centre.

When combined with Cytomatrix’s own technologies in the field of stem cell expansion, we believe that Nohla

Therapeutics Inc. will rapidly become a world leader in the field of cell therapies.

Cytomatrix Ltd holds assets in HeiQ Australia and HeiQ AG, as well as retaining all rights to the development of

biomedical applications of short nanofibres. The Cytomatrix management team has shown an exceptional ability to

realize the full potential of its technologies through a series of transactions through 2014 and 2015 which have

increased shareholder value more than seven fold in 18 months. We anticipate significant potential for further

commercialization of short nanofibres in the fields of wound healing, tissue engineering, coagulation, diagnostic and

many others, leveraging established and highly productive R&D relationships with Deakin and Monash Universities.

PIPELINE

Cytomatrix is currently reconfiguring its business plan following successful sale of its stem cell assets to Nohla

Therapeutics Inc. Utilizing existing grant opportunities through the innovative Manufacturing CRC and the Industry

Transformation Research Hub, together with proceeds from the sale, Cytomatrix Ltd will accelerate development of

key platform applications of short nanofibres in wound healing, artificial skin, slow release of drugs and modulation of

coagulation.

LATEST NEWS

In November 2014 Cytomatrix Ltd entered into a Joint Venture Agreement with Swiss company, HeiQ AG, to develop

the Cytomatrix short nanofibre technology. Under this Agreement, a joint venture company, HeiQ Australia, was

formed to develop manufacturing capabilities for short nanofibres. HeiQ AG retained a license for applications of these

fibres in the fields of textiles and coatings, with Cytomatrix Ltd retained a license for all biomedical applications.

In September 2015 Cytomatrix created a new US company, Nohla Therapeutics Inc (“NTI”), with mirrored shareholding,

and in October 2015 CTI signed an agreement with Fred Hutchinson Cancer Research Center (FHCRC) in Settle,

Washington, to license seven patent families in the field of haematopoietic stem cell expansion and related

technologies. FHCRC is a world leader in bone marrow transplantation, and developed the first successful cord blood

stem cell expan-sion technology (Nature Medicine, 2010, 16(2):232-6). NTI has licensed this technology, together with

new patents in the field of chimeric antigen receptors and NK-cell therapeutics. In November 2015, Cytomatrix Ltd.

sold its stem cell technologies (a novel expansion agent, Ficolin, and 3D cell culture technologies) to NTI.

CEO: Ben Bergo


ABN: 109 903 737

Status: Public unlisted

www.cytomatrix.com.au

CONTACT

Mark Kirkland | Chief Scientific Officer

P: +61 408 395 012

[email protected]


Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. We believe

in the potential of blood to do even more for patients than it does today.

Whether your company is a start-up or well established, taking a new biological product or cellular therapy from

laboratory to market requires a scalable process. Terumo BCT's cell culture technology offers the scalability and

automation these go-to-market projects demand. Addressing this need early—establishing a scalable and

efficient process in the pre-clinical stage of development—protects the commercial viability of your projects.

What's more, adopting scalable processes early may eliminate the need to revalidate or revisit your

manufacturing processes later. Terumo BCT also delivers technologies for secondary cell processing and

dependable tools for maintaining sterility—solutions that support you in developing cell therapies that may

fundamentally improve health care.

PIPELINE

Terumo BCT has a proven history of long-term, sustainable, profitable growth, driven by our innovation pipeline.

We invest over $70 million USD in Research and Development, or what we call “Innovation & Development,” per

year. We pride ourselves on continuous improvement and are always looking for ways to keep pace with the

changing landscape of the industry and the needs of our hospitals, blood centers, laboratories and the donors

and patients we serve.

LATEST NEWS

Athersys, Inc., a biopharmaceutical company, evaluated the use of the Quantum® Cell Expansion

System from Terumo BCT as a manufacturing platform for producing Multipotent Adult Progenitor Cells (MAPC®),

an adherent stem cell product. The combined yield of 10 Quantum systems consistently delivered batches of

more than 9 billion cells that met all safety and quality criteria established for the study. Additionally, results

demonstrated a 40 percent cost savings relative to Athersys' current process.

CEO: David B. Perez

Established in Lakewood, Colorado, USA

Terumo BCT Australia, 2012

ABN: 130 046 865

Status: Terumo BCT Australia is a subsidiary of

Terumo BCT, Inc. (Public Company)

www.terumobct.com

CONTACT

Julia Wenner, PhD | Managing Director

P: +61 (02) 9429 3600


Medical Devices


Laboratory Supply Companies ABN 82 005 914 79

Lewis Cox | Account Manager

P: 1800 656 100

[email protected]

www.bdbiosciences.com/anz

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments and reagent systems to detect a broad range of infectious diseases, healthcare-associated infections (“HAIs”) and cancers. In addition, BD Life Sciences produces research and clinical tools that facilitate the study of cells, and the components of cells, to gain a better understanding of normal and disease processes. That information is used to aid the discovery and development of new drugs and vaccines, and to improve the diagnosis and management of diseases. The primary customers served by BD Life Sciences are hospitals, laboratories and clinics; blood banks; healthcare workers; public health agencies; physicians’ office practices; academic and government institutions; and pharmaceutical and biotechnology companies. BD Life Sciences consists of the following business units: Preanalytical Systems, Diagnostic Systems and Biosciences. The principal product lines in the Biosciences business unit include: Fluorescence-activated cell sorters and analyzers; monoclonal antibodies and kits for performing cell analysis; reagent systems for life science research; molecular indexing and next-generation sequencing sample preparation for genomics research; clinical oncology, immunological (HIV) and transplantation diagnostic/monitoring reagents and analysers; and cell culture media supplements for biopharmaceutical manufacturing.

Bio-Scientific Pty. Ltd., was established in 1972 as a general Laboratory Supply Company providing superior and sought after products to Life Science Research facilities throughout Australia. The Company’s primary focus and objective is providing quality service. Quality Technical support is of the most important functions of the service we provide to the market. In addition, all aspects of Customer service are continually upgraded and improved to address our commitment to Service. Our allegiances with the best logistics companies, our connections within all facets of the regulatory divisions of state and federal bodies and the knowledge and expertise within the life science world, we now move forward to a brighter future with you our loyal customers. One aspect that separates Bio-Scientific from its competitors is that we will at-tempt to source products for our customers from non-represented suppliers. We also believe it is essential to respond immediately to orders for non-stocked items.

Listed below are some agencies that provide products suitable for Stem Cell research: a) Trevigen; b) ReproCELL; c) Jena BioScience; d) Empire Genomics; e) ACRObiosystems; f) Genlantis; g) Celartia; h) Humanzyme; i) Synaptic Systems; j) VLVbio plus others.

ABN: 11 001 405 947

Technical enquiries

Daryn Metti – [email protected]

Pricing and placing orders -

[email protected]

P: 1300 BIOSCI (246724)

www.biosci.com.au



http://www.biosci.com.au


ABN: 20 008 265 969

Andrew Masters | Managing Director P: 0439 819 095

[email protected]

www.coherent.com.au

Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for Liquid, Sample and Cell handling in laboratories worldwide.

Eppendorf’s product range includes pipettes and automated pipetting systems, dispensers, centrifuges, mixers, spectrophotometers and DNA amplification equipment as well as ultra-low temperature freezers, platform and incubator shakers, CO2 Incubators, Bioprocess equipment and cell manipulation systems. Associated consumables like pipette tips, centrifuge tubes, microtiter plates, cell culture consumables and disposable bioreactors vessels complement the instruments for the highest quality workflow solutions.

Our mission is to be a synonym for customer-focused processes, innovative technologies, premium products and services to improve human living conditions.

ABN: 27 086 564 678

Monica Santese Product Manager | Cell and Sample Handling

[email protected]

www.eppendorf.com.au

Coherent Scientific is a specialist supplier of scientific instrumentation to Australasia, exclusively representing Nikon Instruments, Bruker, Coherent Inc, Andor and many other premium vendors. We have supported the scientific community in Australia and New Zealand for over 26 years with expert sales & service teams in every major capital city.

Stem Cell Imaging & Analysis

Nikon’s BioStation IM-Q is a self-contained & self-regulated incubator with phase + fluorescence imaging designed for studies of cell growth, morphology and protein expression. The BioStation CT is a similar but larger capacity imaging system, capable of handling up to 30 different vessels ranging from well plates to culture flasks in a robotised & fully automated incubator.

BioStation systems are compatible with Nikon’s powerful high content analysis software (HCA) allowing multiple assays to be run simultaneously, drastically cutting down the time to data in post-acquisition analysis. Plate heat maps, images, generated binary masks, assay results, sample labelling and other metadata are centralised for quick filtering, gating and drill down to cellular detail.


In Vitro Technologies specialises in the sales, marketing, distribution and support of quality products, systems and tools to the medical, diagnostics, life sciences and industrial sectors throughout Australia and New Zealand. In Vitro Technologies presents a premium portfolio of products for the various aspects of Stem Cell research and therapeutic development, comprising the highest quality reagents, equipment and consumables from around the world. Expansion and differentiation (Stem cell lines - ATCC; Complete stem cell media - R&D Systems; Cytokines and growth factors including GMP proteins - R&D Systems; Serum and base media - HyClone; Falcon Cell Culture Plastic ware and ECM - Corning life Sciences). Verification (Antibodies and stem cell verification kits - R&D Systems; Flow Cytometers - ACEA Biosciences). Investigation (Real-time cell analysers and flow cytometers - ACEA Biosciences; Real-time metabolism analysers - Seahorse Biosciences). Laboratory Equipment (Cryogenic Storage Solutions - Taylor-Wharton; Cell culture scale up solutions - Infors; Biological Safety Cabinets, Incubators and ULT Freezers - NuAire).

ABN: 27 102 379 895

Daina Elliott Sales Manager

P: 1300 552 003 [email protected]

www.invitro.com.au

ABN: 95 111 167 858

Lisa Neville Office Manager


www.lonza.com

Lonza is one of the world’s leading and most trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.

Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 employees worldwide. The company generated sales of about CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Lonza’s stock is publicly traded on the Swiss and the Singapore stock exchanges. Further information can be found at www.lonza.com.

Lonza Australia supplies to researchers adult stem cells and media, growth factors and cytokines from PeproTech, primary cells and media, Nucleofector™ non-viral transfection technology and the MycoAlert™ Mycoplasma Detection System.


http://www.invitro.com.au


Merck Millipore is the Life Science business of Merck, providing innovative tools and laboratory supplies for the life science industry that make research and biotech production easier, faster and more successful.

In Australia Merck Millipore is headquartered in Bayswater, VIC with specialist life science sales and support teams in most states. Merck Millipore is deeply committed to providing novel cell culture systems and characterization tools for stem cell research and primary cell culture. Our highly validated, optimized products provide convenient solutions to many cell culture challenges, so you have time to focus on your research goals.

Merck Millipore offers a comprehensive line of stem cell products including human and murine stem cells, media optimized for stem cell and primary cell culture, growth factors, exclusive antibodies, cultureware, and kits to help you jump start your research.

For process development, pilot and clinical scale the range includes single-use bioreactors, optimized cell culture media formulations and cell culture clarification solutions.

The Stem Cell Research section of our website offers a unique learning centre where you can easily find newly released products, detailed protocols, latest stem cell news, and user-friendly guides to our specialty cell culture products.

ABN 80 001 239 818

Debbie Stanley Marketing Manager


www.merckmillipore.com

ABN: 62 100 017 105

Dr. Hermann Bohnenkamp Managing Director

Phone +61 0405 399 959 [email protected]

www.miltenyibiotec.com

Miltenyi Biotec is one of the world’s leading providers of products and services for biomedical research as well as cell and gene therapy.

MACS® Technology is the gold standard in magnetic cell separation. We offer complete workflow solutions from sample preparation to cell separation, media and cytokines for cell culture, flow cytometry and small ani-mal pre-clinical imaging. Miltenyi Biotec provides expert technical advice and actively participates in research in a wide range of scientific fields including, among other; immunology, cancer, stem cells and neuroscience. We offer GMP cellular therapeutic products and are committed to the promise of cellular medicine in the fields of organ regeneration, immune modulation and transplantation.

Within the stem cell field, our activities address mesenchymal, hematopoietic and cancer stem cells. By devel-oping protocols for GMP-compliant cell separation, differentiation, expansion and formulation, we have been able to sponsor a multicenter phase III clinical trial of CD133-positive hematopoietic cell grafting during CABG surgery and its role in improving post-infarct myocardial regeneration. Currently, our emphasis is on developing great tools for the isolation, analysis, and culture of embryonic stem cells, induced pluripotent stem cells, tissue (e.g. neural, cardiac and hepatic) stem cells and cancer stem cells. Our latest developments focus on re-programming, directed differentiation and enrichment of the resulting differentiated cells.

The company is committed to enabling the delivery of new treatment options to patients with unmet medical need. Miltenyi Biotec’s portfolio of innovative solutions and enabling technologies have set new standards in the industry. The company has more than 1,600 employees in 25 countries and its products have been used in more than 50,000 cell therapy procedures. For more information please visit www.miltenyibiotec.com.

mailto:debbie.stanley@merck

http://www.merckmillipore.com


Sapphire Bioscience distributes over 800,000 research products from over 80 suppliers including Cayman Chemical, Enzo Life Sciences , AdipoGen, Selleck Chem, Abnova and GeneTex. Sapphire Bioscience aims to provide Australian and New Zealand Stem Cell Researchers with superior quality antibodies, biochemicals, small molecules, cytokines, growth factors, cell lysates, ELISA kits, multiplex

kits, assay kits, proteins, tissue slides and more.

ABN: 60 055 311 236

P: +61 2 9698 2022

[email protected]

www.sapphirebioscience.com

PreproTech operates in Australia via a distributor*

Mr. Offir Manor | General Manager, PeproTech Asia [email protected]

www.peprotech.com

Supporting life science research since 1988, PeproTech has a long record of being a trusted manufacturer of high quality cytokine products for the life-science and cell therapy markets.

Since the beginning of stem cell research, a significant part of PeproTech's activity has been focused on this field, offering hundreds of relevant products. PeproTech is continually positioned among the top two cited suppliers in the most prestigious scientific journals in the field, with over 5000 citations each year.

With over 2,000 products, PeproTech has developed and refined innovative production and purification protocols to ensure the quality, reliability and consistency of its products. Our mission is to provide the highest quality products and premium support and customer service that address the needs and requirements of today’s scientific community and the growing landscape of cellular therapy oriented companies. We pride ourselves on being a trusted partner within the basic and applied scientific research community.

Research Use Only (RUO) proteins and antibodies

GMP-Compliant products for Cell, Gene and Tissue Therapy

A wide range of Animal Free recombinant Cytokines

ELISA kits

Stem Cell Culture Media and Kits

Small molecules for stem cell research

Antibodies and Reagents for Flow cytometry

*PeproTech is distributed in Australia by LONZA and in New Zealand directly with an Office in Australia managed by Margret Schuller



STEMCELL Technologies Inc is a privately-owned biotechnology company that develops specialized cell culture media, cell separation products and accessory reagents for life science research. Driven by science and a passion for quality, STEMCELL delivers over 1500 products to more than 70 countries worldwide. STEMCELL has been dedicated to providing standardized reagents and tools for all areas of stem cell research, and has extended this expertise to many other sectors of life science. The importance of quality control processes and raw material selection is critical to the production and optimal performance of STEMCELL’s entire portfolio of products, ensuring that batch-to-batch variability is

minimized.

ABN: 15 128 391 766

Cyndy Nauer Managing Director Asia Pacific

P: 1 800 060 350 [email protected]

www.stemcell.com

Scientifix Pty Ltd is an Australian-owned private company offering innovative research tools and equipment for the life science community since 1998. Scientifix Pty Ltd proudly distributes Takara Bio. Takara Bio is committed to improving the human condition through biotechnology with three primary areas of focus: developing research tools for the life sciences, gene therapy, and nutraceuticals. Takara has been focusing on biomedical research since 1967. Takara Bio has positioned itself as a leading company in the Japanese life science market through the Takara and Clontech brands.

Clontech Laboratories provides kits, reagents, and services that help researchers explore questions about gene discovery, regulation, and function. As a member of the Takara Bio Group, Clontech is part of a company that holds a leadership position in the global market and is committed to improving the human condition through biotechnology. Clontech's mission is to develop high-quality innovative tools and services to accelerate discovery.

Takara Bio Europe AB, formerly Cellartis AB, a subsidiary of Takara Bio Inc., is focusing on stem cell derived products and services for drug discovery, toxicity testing, and applications within regenerative medicine. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media.

ABN: 81 083 311 853

Dr Nikki Tsoudis Director | Lab Products Specialist

[email protected]

www.scientifix.com.au http://www.clontech.com/AU/Products/Stem_Cell_Research


http://www.stemcell.com


VWR International Pty Ltd is a global laboratory supplier for consumables, equipment, chemicals, safety

apparel, life science reagents and services. VWR, formerly Quantum Scientific and Crown Scientific, is

committed to providing the best products with the best service within the Australian scientific community and

industry.

VWR supports BEGINNING-TO-END SOLUTIONS FOR STEM AND PRIMARY CELL RESEARCH through our premium

portfolio from Corning & Falcon, including surfaces for cell expansion, vessels for stem cell culture, advanced

surfaces for cell isolation and derivation, and Matrigel extracellular matrix for stem cell expansion.

At VWR we continue to work with researchers, providing high quality cell culture consumables, as well as

verification tools such as antibodies and ELISA (Bethyl, Abnova and others), transfection reagents (PolyPlus),

and highest quality laboratory equipment (Eppendorf, Panasonic and many others).

With offices in Brisbane, Melbourne and Sydney and Sales Specialists active in all states VWR is well placed to

service its highly valued existing and new clients. For peace of mind, our VWR Technical Service Team provides

a unique combination of service and support for all your equipment.

ABN: 70 145 429 974

Renaud Quantin

Sales Specialist | Life Sciences

P: 0408 870 897

[email protected]

au.vwr.com

ABN: 52 058 390917

Naomi Morison Technical Sales Specialist | Stem Cells


www.thermofisher.com/stemcells

Thermo Fisher Scientific is the world leader in serving science. For over a decade, we have provided the key tools and resources you need to address challenges in stem cell research. Our complete portfolio of Invitrogen and Gibco products and services can support every step of your research and you can benefit from the

continuity, efficiency, and precision that drive discovery.




Table 1. Details of clinical trials run by cell therapy companies listed in the Snapshot *

Company Study

identifier Study title Phase Comparator

Ethics approval

Avita Medical

NCT02458417 Autologous cell suspension grafting using ReCell in

vitiligo and piebaldism patients: a Randomized Controlled Study on the recipient site preparation

4 Control: no

intervention No details available

Avita Medical

NCT01640678 Autologous cell suspension grafting using ReCell in

vitiligo and piebaldism patients: a Randomized Controlled Pilot Study

4

Active comparator: laser and UV or UV only

No details available

Avita Medical

NCT02799121 A feasibility study of the ReGenerCell™ autologous

cell harvesting device for diabetic foot ulcers 4 Uncontrolled


Avita Medical

NCT02380612

Demonstration of the safety and effectiveness of ReCell® combined with meshed skin graft for

reduction of donor area in the treatment of acute burn injuries

N/A Within-subject control


Avita Medical

NCT01743053 A Pilot Trial of the use of ReCell® autologous cell

harvesting device for venous leg ulcers 4 Standard care


Calimmune NCT01734850

An adaptive phase I/II study of the safety of CD4+ T lymphocytes and CD34+ hematopoietic stem/

progenitor cells transduced with LVsh5/C46, a dual anti-HIV gene transfer construct, with and without conditioning with Busulfan in HIV-1 Infected adults

previously exposed to ART

1/2 Uncontrolled No details available

Calimmune NCT02390297

Long Term Follow-up for the detection of delayed adverse events in Recipients of CD4+ T Lymphocytes and/or CD34+ hematopoietic stem/progenitor cells

transduced with LVsh5/C46, a dual anti-HIV gene transfer construct

N/A N/A No details available

Cell Care ACTRN1261300

0186752 A pilot study to assess the feasibility of reinfusion of

cord blood in children at risk of type 1 diabetes. 0 Uncontrolled

Approved by the Sydney Children's Hospitals Network

HREC

Cell Care ACTRN1261600

0403437 Safety study of sibling cord blood cell infusion to

children with cerebral palsy N/A Uncontrolled

Approved by the Royal Children's Hospital

HREC

Cynata CYP-GvHD-P1-

01

An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of

Adults With Steroid-Resistant Acute Graft Versus Host Disease

1 N/A No details available

Mesoblast NCT02032004

The Purpose of This Study is to Evaluate the Efficacy and Safety of Allogeneic Mesenchymal Precursor

Cells (CEP-41750) for the Treatment of Chronic Heart Failure

3

Sham comparator:

control treatment


Mesoblast NCT02362646 Safety & efficacy of intramyocardial injection of

mesenchymal precursor cells on myocardial function in LVAD recipients

2

Sham comparator:

control solution


* Clinical trial registries (clinicaltrials.gov, anzctr.org.au) were accessed between 1/6/16 and 17/6/16. This is not an exhaustive list of studies. HREC: Human Ethics Research Committee; MPC(s): mesenchymal progenitor cell(s); MSC(s): mesenchymal stem cell(s); N/A: not applicable.


Table 1 (Continued). Details of clinical trials run by cell therapy companies listed in the Snapshot *

Company Study


Ethics approval

Mesoblast NCT01781390 Safety study of allogeneic mesenchymal precursor

cell infusion in myoCardial infarction (AMICI) 2 Placebo


Mesoblast NCT02412735 Safety and efficacy study of Rexlemestrocel-L in

subjects with chronic discogenic lumbar back pain (MSB-DR003)

3 Placebo No details available


A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric patients Who Have Failed to Respond to Steroid Treatment for Acute

GVHD

3 N/A No details available

Mesoblast NCT01854567 P3 Study of Umbilical Cord Blood Cells Expanded with MPCs for Transplantation in patients with

Hematologic Malignancies 3

Active comparator:

Control



A Multi-center Study a Single IV Infusion of Allogeneic MPCs in patients with Rheumatoid

Arthritis and Incomplete Response to at Least One TNF Alpha Inhibitor



A Randomized, Controlled, Dose-Escalation Pilot Study to Assess the Safety and Efficacy of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects with Diabetic

Nephropathy and Type 2 Diabetes

1/2 Placebo No details available


A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the

Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells)

Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory

Moderate-to-severe Crohn's Disease


Orthocell ACTRN1261500

0027516

Single-centre, open-label, pilot study of Celgro(tm) collagen membrane for guided bone regeneration

around exposed dental implants in patients undergoing dental implant surgery

N/A Uncontrolled

Approved by St John of

God Health Care HREC


0532606

Repair of Symptomatic Ear Drum Perforations: A Pilot Study using Celgro Trademark Type I/III

Collagen Bioscaffold 1/2 Uncontrolled

Approved by South

Metropolitan Health Service HREC


0383864

Patients with gluteal tendinopathy who undergo autologous tenocyte implantation will have

improved clinical and radiological outcomes at 3,6,12 and 24 months post injection

N/A Uncontrolled Not yet

submitted



Table 1 (Continued) . Details of clinical trials run by cell therapy companies listed in the Snapshot*

Company Study


Ethics approval


0402448 Autologous Tenocytes Therapy to Improve the

Healing Process of Tennis Elbow 1/2 Uncontrolled

Approved by Sir Charles Gairdner Hospital

HREC

Orthocell EUCTR2010-

021869-73-NL

The value of Autologous Tenocyte Implantation in patients with chronic Achilles tendinopathy: a

double-blind randomised clinical trial - ATI in Achilles tendinopathy

Placebo No details available

Regeneus ACTRN1261500

0516583

In patients with advanced solid tumours, is an autologous cancer vaccine (RGSH4K), safe and tolerable, and can a biologically active dose be

identified?

1 Uncontrolled Approved by Bellberry Ltd


0476538

Patients with solid tumours that are accessible can bank their tumours in a dedicated tumour bank for long term fresh frozen storage conditions for the

possible future production of an autologous cancer vaccine, the latter being a separate study.

N/A N/A Approved by

Bellberry HREC


0439549

A Phase 1 Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate

the Safety, Tolerability and Preliminary Efficacy of Intra-articular Progenza (PRG) in adults with

Symptomatic Knee Osteoarthritis

1 Placebo Approved by

Bellberry HREC


0672853

A Registry of Autologous Non-Expanded Adipose Derived Stem Cells (HiQCellTM) in the Treatment of

Osteoarthritis to determine prevalence of joint infections

N/A N/A Approved by Bellberry Ltd


1046998

A Randomised Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of Autologous Non-

Expanded Adipose Derived Stem Cells In The Treatment Of Knee Osteoarthritis

N/A Placebo

Approved by Hawkesbury

HREC of Northern Sydney Central

Coast Health

TerumoBCT NCT02298842 In-Vitro Study of Platelets Collected on Trima Accel

System and Stored in InterSol Solution N/A

Platelets stored in plasma


TerumoBCT NCT02754492 Evaluation of the Performance of Trima Accel®

Version 7.0 Software Enhancements for the Collection of Platelets Stored in 100% Plasma

N/A Uncontrolled No details available

TerumoBCT NCT02754440

Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the

Collection of Platelets Stored in Platelet Additive Solution

N/A Uncontrolled No details available

TerumoBCT NCT02684630 A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in

Volunteer Blood Donors N/A Uncontrolled


TerumoBCT NCT01907906 Inactivation of Whole Blood with Mirasol : Performance in Red Blood Cells in Healthy

Volunteers 1 Uncontrolled



snapshot of stem cell companies in...

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