Know what is being put into your joint

Each procedure should have clear contents

PRP is the short name for platelet-rich plasma. To prepare it, the clinic draws and spins your blood. The plasma, its liquid part, then contains more platelets, small blood parts that gather at a cut. The provider places this concentrated blood in the aching joint.

A marrow procedure draws bone marrow from your pelvis, spins it, and returns the concentrated marrow liquid to the joint. A fat procedure takes a small amount of body fat, processes it, and puts the fat-based liquid into the joint. It won't contain the same mix of cells for every person.

These procedures are offered in hopes of easing soreness, but relief isn't certain.

Federal registration does not approve joint use

When a clinic says its offering is registered, the clinic or maker has sent identifying details to the federal drug agency. The filing tells the agency who handles it. It isn't proof that the contents were checked for safety or shown to work for a sore joint. Registration also doesn't give permission for that joint use.

Slow down here. Ask whether the exact blood, marrow, or fat procedure has federal approval for the joint use being offered. Get a plain yes or no. If the reply answers a different question, ask again.

You're gathering facts before someone puts anything into your joint.

QC Kinetix explains its care before you decide

QC Kinetix offers regenerative treatments for joint soreness. In ordinary words, these are non-surgical clinic procedures that may use blood drawn from you and spun at the clinic. Its medical providers examine your joint, give the care, and should explain the exact contents before anything is done.

Ask how sore you may feel afterward, what follow-up is included, and what the full cost will be. Also ask what happens if you don't feel relief. The answer shouldn't promise repair or a fixed result.

Take your time with the decision.

Sources

1. The International Society for Cell & Gene Therapy position statement holds that the acronym MSC should mean mesenchymal STROMAL cells and should only be called stem cells where rigorous in vitro and in vivo evidence of stemness exists for that specific preparation.

   Viswanathan S, et al. — Mesenchymal stem versus stromal cells: International Society for Cell & Gene Therapy (ISCT®) Mesenchymal Stromal Cell committee position statement on nomenclature. Cytotherapy, 2019. DOI: 10.1016/j.jcyt.2019.08.002.

2. The 2018 AAOS/NIH consensus work group recommended that minimally manipulated mixed cell preparations be called CELL THERAPY rather than stem cell therapy, and that their untested and uncharacterised nature be clearly communicated to patients and the public, because stem cells have properties these preparations do not meet.

   Chu CR, et al. — Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg, 2019. DOI: 10.5435/JAAOS-D-18-00305.

3. 21 CFR 1271.10(a) sets the four criteria a human cell or tissue product must meet to be regulated SOLELY under section 361 of the Public Health Service Act: it must be minimally manipulated; intended for homologous use only, as reflected by labeling and advertising; not combined with another article beyond water, crystalloids or a preserving agent; and either have no systemic effect and not depend on the metabolic activity of living cells, or else be for autologous use, use in a close blood relative, or reproductive use.

   US Code of Federal Regulations, Title 21 — 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act. , 2004.

4. FDA states in its consumer alert that the only FDA-approved stem cell products in the United States are blood-forming stem cells derived from umbilical cord blood, approved for disorders of the blood-forming system, and that NONE of these products - stem cells, stromal vascular fraction, umbilical cord blood, Wharton's jelly or amniotic fluid - has been approved for the treatment of any orthopedic condition, including osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain or shoulder pain.

   US Food and Drug Administration, Center for Biologics Evaluation and Research — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. , 2020.

5. MACI is FDA-licensed (STN BL 125603, Vericel Corporation) and is indicated for the repair of symptomatic, single or multiple FULL-THICKNESS cartilage defects of the knee with or without bone involvement in adults - a focal defect repair performed surgically, not a treatment for osteoarthritis and not an injection.

   US Food and Drug Administration — MACI (autologous cultured chondrocytes on porcine collagen membrane). , 2016.

6. On 27 September 2024 the Ninth Circuit held in United States v. California Stem Cell Treatment Center that stromal vascular fraction produced by enzymatically digesting a patient's own fat IS a drug under the Federal Food, Drug, and Cosmetic Act, and that the same surgical procedure exception does not apply because the removed fat and the implanted SVF are not the same thing. The district court's ruling for the clinics was reversed.

   United States Court of Appeals for the Ninth Circuit — United States v. California Stem Cell Treatment Center, Inc., No. 22-56014 (9th Cir. Sept. 27, 2024). , 2024.

7. In orders issued 26 December 2024 and announced 8 January 2025, a federal court permanently banned the co-founders of the Stem Cell Institute of America and their companies from marketing any regenerative medicine treatment, and ordered $5,155,146 in refunds and civil penalties. The court found on summary judgment that they published false and misleading advertisements about the efficacy and approval of stem cell injections for osteoarthritis, neuropathy and joint pain; their clinic charged up to $5,000 per injection and the customers were almost exclusively elderly and disabled people.

   US Federal Trade Commission — Stem Cell Institute Co-Founders and Companies Banned from Marketing Stem Cell Treatments and Ordered to Pay More Than $5.1 Million for Refunds and Civil Penalties. , 2025.