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Stem Cell Injections in AthletesTroy S. Watson, MDDirector, Foot and Ankle InstituteDesert Orthopaedic CenterLas Vegas, NV
Stem cells are far from mainstream – NFL teams will typically not pick up the bill, and the overseas market for treatments not approved in the US makes the whole field seem somewhat taboo.
What is a STEM CELLUnspecialized cellsRetain the ability to divideCan differentiate into specialized cellsContribute to the bodies ability to renew and repair its tissues
Stem CellsEmbryonic stem cellsMay be controversialDerived from unused embryos Placenta (AM) and umbilical cordAdult stem cellsMesenchymal stem cells found in bone marrow and adipose tissue most interesting to orthopaedic surgeons
What is a STEM CELL
What is a STEM CELL
Use of stem cells in foot and anklePlantar fascitisOCD lesions of talusAchilles tendonitisPeroneal tendon issuesLigament sprainsEarly arthrosisImproved bony healingFusions and fracturesRestore functionAccelerate healingReduce adhesions
Stem Cell Use BoomingModern Day Snake Oil?
Tony Dorsett Chronic Traumatic Encephalopathy (CTE)Celltex cultured and multiplied mesenchymal cells from adipose tissue with the aid of bovine serum
Dynamic Stem Cell Therapy
What are Stem Cells?Allowable by FDAAutologous stem cellsBone marrow aspirate concentrateAdding auto blood productPRPFibrin glue (PPP)Using centrifuge to concentrateAmniotic fluidForbidden in US by FDACulturing cellsIncreases concentration of cellsTake cells out of OR/ClinicAdding growth factorsAdding enzymes (collagenase) to aid harvest
Regenexx Website
Types of Stem CellsMesenchymal Stem CellsBone marrow derivedHarvest from PSIS, ASIPMany commercial systems available to harvestBMA contains few progenitor cell.01% or 1 in 100,000Centrifuge used to concentrate
Technology Changes Everything
Chris Johnson
BMAC vs BMAC culturedIllegal in US until FDA approvedStem cells removed and culturedBMAC may lead to 10,000 mesenchymal cellsCulture takes 10-14 daysMay yield ~ 2 million mesenchymal cellsAvailable in Cayman Islands, Russia, North Korea, Japan, Germany
Types of Stem CellsAdipose Derived Stem CellsRichest source of MSCsEasy harvestLiposuction or arthroscopyMinimal morbidityLarge cell yieldNo culture to expandNo decline with agingaquavage
Allosource Preclinical Study
Adipose Harvest AdiPrep
IntelliCell BioSciencesMini-liposuction of adipose tissue (60cc)Ultrasound technology to separate the vascular tissue from adipocytesVascular tissue is decanted, washed and centrifugedFlow cytometry is completed Cell count and cell viabilityExcess may be cryopreserved for future treatments
Kobe, A-Rod, Fred Couples Visit GermanyRegenokinePeter Wehling, MDNot stem cell treatmentSerum from blood incubated with zinc etched glass beads, then centrifugedInterleukin 1 Receptor Protein, a natural anti-inflammatoryReal deal or expensive placebo?
What About Amniotic Tissue?AM/UCHigh concentration of growth factorsMultipotent differentiationImmune-privilegedAnti-inflammatoryAnti-adhesionsAnti-microbial
Shelf Stable2 year shelf life at room temperatureEasily InjectableMix with saline / sterile water to achieve desired volume & concentrationInjectable in as small as a 26 ga needleIdeal for In-Office TreatmentMarketable and economically viable injectable alternativeAvailable for conservative treatment of common issues:Plantar FasciitisTendonitis/TendinosisAMNIOX CLARIX® FLO INJECTABLE: In-Office Solution for Inflammatory ConditionsLigament DamageJoint Pain / ScarringDelivering the clinical and economic power of CLARIX into your doctor’s practice with a proven and effective UC/AM injectable
Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.Zelen CM1, Poka A, Andrews J.FAI, Oct 2013Micronized dehydrated human AMInjected for Plantar fascitisBy week 8 both the 0.5cc and 1.25cc group showed significant improvement vs control group (p<.001)No difference between 0.5 and 1.25 cc groups
44 patients with dx of plantar fascitis or Achilles tendinosisFailed 6 months of conservative treatmentInjected with PalinGen SportFLOW Live cells from AM/AF harvested and cryopreservedVAS improved from 8 pre injection to a 2 post injection at 12 weeks
World Anti-Doping AgencyStem Cells are currently not prohibitedDepends how cells are manipulatedCannot offer performance enhancing benefitsCannot justify a positive doping test of any banned substance
Is This Covered?Since no CPT code is available, this is a CASH only procedureCan charge for use of ultrasoundLimited musculoskeletal US (76882)US guided injection (76942)In USPRP: $500-2000BMAC: 4k-8KOutside USBMAC: 4-8K20K-70KUsually includes culturing cells
ConclusionsStem Cell therapy is likely here to stayLittle data available in US to suggest who and what dx benefitsNeed clinicians to track outcomes data? OFAR, SOS