What should you know about approval and cost?

What are you paying for?

PRP begins with a blood draw from your arm; a machine spins it. Marrow and fat procedures take more work and may cost more.

A price may include follow-up care or more than one procedure. You won't know what's included without a written list before you pay.

For this care, QC Kinetix offers orthobiologics for soreness, meaning medical providers first check the joint and use either your blood or your marrow. The clinic can put each cost beside the care it covers.

Does government review mean the treatment works?

Blood- and marrow-based joint care doesn't have government approval for sore joints. A blood-spinning machine may still be allowed for sale.

Permission to sell the machine doesn't show that the joint procedure works. The machine and the care receive different kinds of review.

A public study listing only says that someone recorded planned research. It doesn't make the care approved or prove relief.

What safety questions are worth asking?

A needle placed into a joint brings some risk of infection. Marrow and fat also leave a sore place where material was taken.

You can ask who prepares the material and does the procedure. Keep a phone number for worsening soreness, redness, or swelling.

No honest answer can promise that nothing will go wrong. You'll want clear steps for getting help if trouble starts.

Sources

1. FDA states verbatim of stem cell products, stromal vascular fraction (adipose-derived cells), umbilical cord blood, Wharton's jelly, amniotic fluid and exosome products: 'None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.' The only FDA-approved stem cell products in the United States are blood-forming (hematopoietic progenitor) cells derived from umbilical cord blood, approved only for disorders of blood production, and there are currently NO FDA-approved exosome products.

   U.S. Food and Drug Administration — Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA (Center for Biologics Evaluation and Research), 2020.

2. FDA's July 2020 final guidance 'Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use' is the document that decides whether a given orthobiologic can be used without a licence: an HCT/P may be regulated solely under section 361 only if it is minimally manipulated AND intended for homologous use, among other criteria; otherwise it is a drug or biological product requiring an approved licence or an active investigational new drug application.

   U.S. Food and Drug Administration — Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use - Guidance for Industry and Food and Drug Administration Staff. FDA Guidance Document, 2020.

3. FDA's patient and consumer notice on regenerative medicine states that it has received reports of BLINDNESS, TUMOUR FORMATION, neurological events, bacterial infections including life-threatening blood infections, unwanted immune reactions, and cells migrating and forming unintended tissue, following the use of unapproved regenerative medicine products - a list that explicitly includes stromal vascular fraction, amniotic fluid, Wharton's jelly, ortho-biologics and exosomes. It also warns that a product's presence on clinicaltrials.gov, or a firm's registration with FDA, does NOT mean the product is legally marketed.

   U.S. Food and Drug Administration — Important Patient and Consumer Information About Regenerative Medicine Therapies. FDA (Center for Biologics Evaluation and Research), 2021.

4. In January 2025 federal district court orders resolving a joint FTC and Georgia Attorney General complaint permanently BANNED the co-founders of the Stem Cell Institute of America and several related companies from marketing stem cell therapy, and required payment of $5,155,146 in civil penalties and consumer refunds. In March 2024 the court had granted summary judgment on all counts, finding the defendants created and published false and misleading advertisements about the efficacy of stem cell injections. The affiliated clinic charged up to $5,000 per injection, almost exclusively to elderly and disabled consumers.

   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. FTC Press Release, 2025.

5. Medicare's national coverage determination states that CMS covers autologous platelet-rich plasma ONLY for patients with chronic non-healing diabetic, pressure and/or venous wounds, and only inside an approved coverage-with-evidence-development clinical study. Every approved study listed under the NCD is a wound-healing study. There is no Medicare national coverage for PRP in osteoarthritis or tendinopathy, which is why these injections are billed to the patient.

   Centers for Medicare & Medicaid Services — Autologous Platelet-rich Plasma (Coverage with Evidence Development). CMS.gov, 2024.

6. A cross-sectional study contacted 273 of 317 US centres offering direct-to-consumer stem-cell therapy, posing as a 57-year-old man with knee osteoarthritis. The mean advertised price of a unilateral same-day stem-cell knee injection was $5,156 (SD $2,446; 95% CI $4,550-5,762, n=65) and the mean claimed clinical efficacy was 82% (SD 9.6%; n=36) - a figure the authors describe as a gap between marketing claims and the published literature.

   Piuzzi NS, et al. — The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective.. Journal of Knee Surgery, 2018. DOI: 10.1055/s-0037-1604443.