PUTTING IT ALL TOGETHER: PUTTING IT ALL TOGETHER: Practical Approach Knee OA Patients Practical Approach Knee OA Patients Interested in Regenerative MedicineInterested in Regenerative Medicine

Jay Smith, MDJay Smith, MD

Professor & Vice-Chair of of PM&RProfessor & Vice-Chair of of PM&R

Departments of PM&R, Radiology & AnatomyDepartments of PM&R, Radiology & Anatomy

Mayo Clinic, Rochester, MNMayo Clinic, Rochester, MN

AAPM&R 2015AAPM&R 2015

REGEN MED CONSULTREGEN MED CONSULTDisclosuresDisclosures

• Off-label use Off-label use • PRP, BMCPRP, BMC

• Speaking honorariumSpeaking honorarium• Gulf Coast Ultrasound InstituteGulf Coast Ultrasound Institute

• Stock/RoyaltiesStock/Royalties –– TENEX HealthTENEX Health

• Stock/CMO Stock/CMO –– Sonex HealthSonex Health

REGEN MED CONSULTREGEN MED CONSULTLearning ObjectivesLearning Objectives

• Discuss approach to patient with knee OA Discuss approach to patient with knee OA interested in regenerative medicine optionsinterested in regenerative medicine options

• PracticalPractical• Patient encounterPatient encounter• Best available scienceBest available science• Level V evidenceLevel V evidence

• Focus on PRP & BMCFocus on PRP & BMC• Prolotherapy Prolotherapy • Structural fat graftsStructural fat grafts• OtherOther AMSCs – Mayo

REGEN MED CONSULTREGEN MED CONSULTClinical PresentationClinical Presentation

• 60 y Male with left knee OA60 y Male with left knee OA• ‘’‘’Can those stem cells cure my arthritis?”Can those stem cells cure my arthritis?”• ““Dr. X said you can regrow my cartilage.”Dr. X said you can regrow my cartilage.”

REGEN MED CONSULTREGEN MED CONSULTBe a Good DoctorBe a Good Doctor

Perform a comprehensive physiatric evaluationPerform a comprehensive physiatric evaluation

•Confirm diagnosisConfirm diagnosis

•Ensure reasonable prior RxEnsure reasonable prior Rx• Standard of careStandard of care

•Identify co-morbiditiesIdentify co-morbidities• Influence regen med optionsInfluence regen med options• Modify expected outcomesModify expected outcomes

•Determine functional limitations & patient goalsDetermine functional limitations & patient goals• ““What do you want to achieve?”What do you want to achieve?”

REGEN MED CONSULTREGEN MED CONSULTHistory: Sx Profile & Past EvalHistory: Sx Profile & Past Eval

• Presenting symptomsPresenting symptoms• Functional consequencesFunctional consequences

• Prior evaluationPrior evaluation

• Prior imagingPrior imaging• Standing X-rays < 1 yrStanding X-rays < 1 yr• AlignmentAlignment

• MRI?MRI?• Bone marrow lesionsBone marrow lesions• Meniscal extrusionMeniscal extrusion

REGEN MED CONSULTREGEN MED CONSULTHistory: Assess Prior TreatmentsHistory: Assess Prior Treatments

• Activity modificationActivity modification

• Weight lossWeight loss

• PT/ExercisePT/Exercise• StrengthStrength• AerobicsAerobics• OtherOther

• Bracing/WedgesBracing/Wedges

• ModalitiesModalities• PEMF, TENS, etc.PEMF, TENS, etc.

• MedsMeds• OralOral• TopicalTopical

• SupplementsSupplements

• InjectionsInjections• CortisoneCortisone• Hyaluronic acidHyaluronic acid• RegenRegen

• SurgerySurgery Underline – AAOS GuidelinesUnderline – AAOS Guidelines

REGEN MED CONSULTREGEN MED CONSULTHistory: Prior Treatments – Why?History: Prior Treatments – Why?

• Identify and discuss gaps in prior treatmentsIdentify and discuss gaps in prior treatments• Reinforce importance of holistic approachReinforce importance of holistic approach• (Re)-implement prior to regen med(Re)-implement prior to regen med• Integrate into regen med Rx planIntegrate into regen med Rx plan

• Assess patient’s dedicationAssess patient’s dedication

• Identify prior adverse reactionsIdentify prior adverse reactions• Needle/procedure-phobicNeedle/procedure-phobic• Reaction to prior regen RxReaction to prior regen Rx

REGEN MED CONSULTREGEN MED CONSULTHistory: Importance of Medical HxHistory: Importance of Medical Hx

• May benefit from “medical tune-up” firstMay benefit from “medical tune-up” first• Metabolic syndrome = pro-inflammatoryMetabolic syndrome = pro-inflammatory

• Disclose limited knowledge & experienceDisclose limited knowledge & experience• Safety of PRP & BMC reasonably establishedSafety of PRP & BMC reasonably established• Systemic inflammatory/autoimmune D/O’s?Systemic inflammatory/autoimmune D/O’s?• Chronic infections (e.g. HIV, Hepatitis)?Chronic infections (e.g. HIV, Hepatitis)?• Hematological (incl. marrow) disorders?Hematological (incl. marrow) disorders?• History of cancer?History of cancer?

Honest discussion & documentationHonest discussion & documentation

Discuss/obtain permission from caregiversDiscuss/obtain permission from caregivers

REGEN MED CONSULTREGEN MED CONSULTHistory: Medications/SupplementsHistory: Medications/Supplements

• PRPPRP• Avoid NSAIDs 1-2 weeks before (?after?)Avoid NSAIDs 1-2 weeks before (?after?)• Others?Others?

• BMC (BMSCs)BMC (BMSCs)• ImmunosuppressivesImmunosuppressives• StatinsStatins• Others?Others?

Recommend common sense approachRecommend common sense approach

Consider risks-benefits of medication changesConsider risks-benefits of medication changes

REGEN MED CONSULTREGEN MED CONSULTHistory: Final ConsiderationsHistory: Final Considerations

• Document date of last physical examinationDocument date of last physical examination• < 1 year< 1 year• Screening testsScreening tests• Lab testsLab tests

• Communicate with caregiverCommunicate with caregiver• ““Permission”Permission”• Medication modificationsMedication modifications• Further evaluationsFurther evaluations

REGEN MED CONSULTREGEN MED CONSULTPhysical ExaminationPhysical Examination

• KneeKnee• GaitGait• AlignmentAlignment• Motion lossMotion loss• InstabilityInstability• Mechanical SxsMechanical Sxs

• Hip/Spine/NeuroHip/Spine/Neuro

• Be sure it is a regen med treatable knee problemBe sure it is a regen med treatable knee problem• Tendinosis, CPPD/gout, saphenous neuritisTendinosis, CPPD/gout, saphenous neuritis

REGEN MED CONSULTREGEN MED CONSULTImagingImaging

• Standing radiographsStanding radiographs• K-L stagingK-L staging• Alignment Alignment

• MRIMRI• Bone marrow lesionsBone marrow lesions• May be painful May be painful • Recognized & treated?Recognized & treated?• OsteonecrosisOsteonecrosis

• Meniscal extrusion?Meniscal extrusion?

Choi Eur J Orthop Surg Traum 2014

REGEN MED CONSULTREGEN MED CONSULTDiscussion & Treatment OptionsDiscussion & Treatment Options

Discuss diagnosis & Rx optionsDiscuss diagnosis & Rx options

•Review “standard of care” Rx optionsReview “standard of care” Rx options• Context of prior RxContext of prior Rx• Do nothing Do nothing surgery surgery

•Review regen med Rx optionsReview regen med Rx options• Off-label, non-reimbursedOff-label, non-reimbursed

•Discuss patient specific options:Discuss patient specific options:• EvaluationEvaluation• Patient preferencesPatient preferences• Patient goalsPatient goals

REGEN MED CONSULTREGEN MED CONSULTRx Options: Standard of CareRx Options: Standard of Care

• Consider “standard of care” optionsConsider “standard of care” options• Lateral wedge/brace Lateral wedge/brace • Trial of crutches (e.g. BML)Trial of crutches (e.g. BML)• ““Need quick fix” – cortisoneNeed quick fix” – cortisone

• Preparation for later regen RxPreparation for later regen Rx

• Surgery may be best optionSurgery may be best option

REGEN MED CONSULTREGEN MED CONSULTRx Options: PRPRx Options: PRP

• Discuss rationale, preparation & deliveryDiscuss rationale, preparation & delivery

• Multiple studies, including RCTsMultiple studies, including RCTs

• Reasonably safeReasonably safe

• Physiologic > RegenerativePhysiologic > Regenerative

• Slower onset vs. cortisone Slower onset vs. cortisone

• 40-60% improvement X 6-12 mos.40-60% improvement X 6-12 mos.

• May be better in K-L 1-2May be better in K-L 1-2

• Can be repeated (long term safety?)Can be repeated (long term safety?)

REGEN MED CONSULTREGEN MED CONSULTRx Options: BMCRx Options: BMC

• Discuss rationale, preparation & deliveryDiscuss rationale, preparation & delivery• CE vs. BMC/BM-MNCsCE vs. BMC/BM-MNCs• Details regarding BMADetails regarding BMA

• Few studies, no RCTsFew studies, no RCTs

• Reasonably safeReasonably safe

• Mechanism of action?Mechanism of action?

• PotentialPotential disease modification disease modification• Expanded vs. BMC/BM-MNCsExpanded vs. BMC/BM-MNCs

REGEN MED CONSULTREGEN MED CONSULTRx Options: BMCRx Options: BMC

• 50% chance of 50% chance of >> 50% improvement 50% improvement• 50-60% improvement (wide variability)50-60% improvement (wide variability)• Not all respondNot all respond

• May be slow onset (> 3 months)May be slow onset (> 3 months)

• Max improvement 3-6 monthsMax improvement 3-6 months

• Durability?, but hope Durability?, but hope >> 12 months 12 months

• Can be repeated, long term safety?Can be repeated, long term safety?

• More effective in K-L 3-4 vs. PRP?More effective in K-L 3-4 vs. PRP?

REGEN MED CONSULTREGEN MED CONSULTDecision-Making & DocumentationDecision-Making & Documentation

• Discuss off-label use of PRP and BMCDiscuss off-label use of PRP and BMC• Discuss FDA positions (e.g. SVF)Discuss FDA positions (e.g. SVF)

• Discuss non-coverage by third party payorsDiscuss non-coverage by third party payors• ABNs/WaiversABNs/Waivers

• Set realistic expectationsSet realistic expectations• Be honestBe honest• Under-promise & over-deliverUnder-promise & over-deliver• ““At worst it’s a waste of time and money”At worst it’s a waste of time and money”

• DocumentDocument

REGEN MED CONSULTREGEN MED CONSULT

THANK YOUTHANK YOU

Questions & DiscussionQuestions & Discussion