vail symposium stem cell panel dr. centeno

What’s the Future of

Orthopedics and Will Stem Cells

Play a Role?

by Christopher J. Centeno, MD,

Centeno-Schultz Clinic, Broomfield, CO

http://www.centenoschultz.com/about/our-staff/

Let’s start with a 30,000 foot view…

This is what greeted me in almost every 50+ year old patient I admitted to the hospital as a medical

student in the 1980s:

In the last 30 years, almost all open heart surgery has been replaced by “percutaneous” (read

needle and catheter based) devices…

2000 2015 2030

Surgical Percutaneous Surgical Percutaneous Surgical Percutaneous

Because of cell therapies, the future of orthopedics will also be less surgery and more injections…

“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”

• 1,200 square foot clean room for same day cell processing

• Privately funded separate “research only” lab that looks like any university facility

Our Colorado practice is different…

Processing

Research

Clinic

Research…

ELISA

Real-time PCR

Flow Cytometry

Flo

ure

scent

Mic

ro

Inversion

Micro

Normoxic and Hypoxic Culture

-150 C Cryo

Advanced Centrifugation

ISO Class 7 Clean Room

ISO Class 5 BSCs

FACS

Our Process

Clinical

Research

Track Patients in

our Registry

Use Data to Guide

Treatment Decisions

Publish

Innovate In the

Lab


Published Research Randomized Controlled Trials:

Same day isolated stem cells now recruiting:

-Knee Osteoarthritis-Chicago-Knee ACL Injury-Colorado-Shoulder Rotator Cuff Tears-Colorado-Low Back Sciatica-Colorado

FDA Clinical Trail for cultured stem cells (through licensed publically traded company):

-Low Back Disc Bulges-Entering Phase 1

Patients Tracked in Clinical Registry:

Total approx. 3,500 patients treated at 20+ sites in the U.S. and Grand Cayman:

-Knee Arthitis-Knee ACL Tears-Knee meniscus tears-Hip arthritis-Hip labral tears-Shoulder arthritis-Shoulder rotator cuff tears-Elbow UCL ligaments tears-Hand/wrist arthritis-Ankle ligament tears-Foot/ankle arthritis-Low back sciatica-Low back disc bulges-Degenerative disc disease

In the world literature, our research group has published on 29% or 1,457 of the 5,029 patients who have received stem cell treatments for orthopedic conditions…


What types of autologous stem cell procedures are being performed for Orthopedic injuries?

The biggest allogeneic “stem cell” treatment right now is amniotic:

• These therapies contain few if any living stem cells once they are freeze dried or frozen, shipped, and shock thawed

• Hence these are not really stem cell treatments

• Very little data on efficacy or safety when used for orthopedic indications

Two Different Types of Bone Marrow Stem Cell Processes

Bone MarrowNucleated Cell

IsolationThe stem cell fraction

of bone marrow is isolated via a

centrifuge and re-injected the same day.

Bone Marrow Mesenchymal Stem

Cell CultureThe stem cells themselves are isolated and cultured to greater numbers over a few weeks. This produces

a “pure” population of stem cells which is

different than the mix of cells produced by same

day procedures.

Simple Adipose Graft

The fat is separated from the oil and

liquid and the fat is injected (however the stem cells are

still trapped in the fat and are not

concentrated).

Stromal Vascular

Fraction (SVF)The fat is separated and then chemically digested to release

the stem cell fraction, which is

then concentrated.

Adipose Mesenchymal

Stem Cell CultureThe stem cells are

isolated and cultured to greater numbers over a few weeks. This produces

a “pure” population of stem cells which is different

than the mix of cells produced by same day

procedures.

Three Different Types of Fat Stem Cell Processes

Sam

e D

ay

Sam

e D

ay

Sam

e D

ay

Ad

van

ced

Ad

van

ced

DrugNeeds FDA Approval



TissueNo FDA Approval

TissueNo FDA Approval

Au

tolo

gou

s“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”

Let’s follow some examples of how

orthopedics will change…

What happened to the knee?

Does an ACL injury benefit from surgery?

-2/3rds of teens who get ACL surgery will have arthritis by the time they’re 30 (Mar 2014 AAOSM Meeting)…

-The knee after ACL surgery never regains the same position sense (Knee. 2013 Dec;20(6):532-6.)

-There is no difference in return to sport between patients who get ACL surgery and those who don’t (JBone Joint Surg Am. 2014 Aug 6;96(15):1233-1241.)

What if we could heal an ACL through an ultra-precise injection of stem cells?

This ACL had only an injection of the patients' own stem cells using a specific protocol…


More examples…


How about knee arthritis?

0

10

20

30

40

50

60

70

80

For demographics, N for age calculation was 998, for BMI 925. Numbers of patients followed up for outcomes were the following: 461 at 1 month, 444 at 3 months, 371 at 6 month, 232 at 12 months,154 at 18 at months,100 at 24 at months and 47 at 36 months, 10 at 48 months. The expected follow-up Ns were: 928 at 1 month, 838 at 3 months, 699 at 6 months, 447 at 12 months, 307 at 18 months, 211 at 24 months, 97 at 36 months, 20 at 48 months. There we 67 study exits during the 4 year period, with 19 due to TKA. It also should be noted that 7 of the 35 patients due to report at 4 years had reported needing a TKA. Study exits were not counted above in the expected follow-up Ns at any given time point as they had refused additional follow-up.

Regenexx-SD

N 999 procedures

Male 604 (60.5%)

Female 395 (39.5%)

Age 55.5 (13-92)

Height 68.1”(49-83)

Weight 177 (100-315) lbs.

BMI 26.8 (16-55.8)

Patient DemographicsWhat’s important here? The patient

results detailed on this infographic are mostly men who are middle aged and only slightly overweight (BMI>25).

Kn

ee A

rth

riti

s0

10

20

30

40

50

60

70

80

90

100 Percentage of Patients Reporting >50% Improvement

Mean Improvement of All Patients

18 U.S. sites


Details For Analysis: Patients with available pain scores were 710, 396, 402, 307, 155, 102, 82, and 46 at the sequential time points (starting at pre-treatment and ending with 36 months post-treatment). Patients with available LEFS score were 662, 388, 394, 290, 149, 98, 78 and 43 at the same sequential time points. It should be noted that this dataset contains both Regenexx-SD and Regenexx-SD Plus cases.

Pain and Function DataFall 2014 710 Treated Patients

0

1

2

3

4

5

1-1

0 P

ain

Sc

ale

Re

po

rte

d Means of pain scale reported by patients

40

45

50

55

60

65

70

LE

FS

LEFS means reported by patients

18 U.S. sites

Kn

ee A

rth

riti

s


Can we improve outcomes by dramatically changing how stem cells are processed?

Ge

n 1

Ge

n 2

Ge

n 1

Ge

n 2

Ge

n 1

Gen

2

Function 0-10 N.P.S. Self-report

Gen1 n=109Gen 2 n=92

Difference=0.03

Gen1 n=121Gen 2 n=99

Difference=0.0001

Gen1 n=278Gen 2 n=114

Difference=0.17


What does the next 15-30 years look like?

• Orthopedics will become more injection based

• New cell based therapies will change the mantra from “cut” to “heal”

• Fewer joint replacements

• Advanced needle and catheter based devices will be developed in orthopedics, just like what happened in cardiology

Conclusions:• Stem cells and other cell based therapies will turn the

orthopedics world upside down-benefitting patients

•Already, our group is beginning to challenge the concept that ACL surgery will be needed for most patients

•We can already manage arthritis in many joints and help many patients avoid more invasive joint replacement

vail symposium stem cell panel dr. centeno

Documents