What to ask about the rules for treatment

What to ask about the proposed treatment

Write down the treatment's full name. Ask whether it contains your blood, bone marrow, donated cells, or a drug. Then ask where each part comes from. A general label can't tell you what you may receive.

If it uses your blood or bone marrow, ask how staff prepare it. Ask why that exact treatment fits your exam and health history. A doctor should explain every step in common words. Compare that answer with the treatment papers before you decide.

What to ask about safety and rules

Ask which risks matter most for you and how staff lower them. Find out which symptoms after treatment need a quick call. Know the phone number and the person who answers before you agree.

Ask which federal rule lets the clinic offer that treatment for your joint. Request the product label, written rule, or court paper supporting its answer. Check that the paper covers the same treatment, preparation, and use. If it doesn't, take more time before deciding.

What to do before agreeing

Bring earlier scan pictures and the doctor's written reports. Ask whether another exam might point to different care. A doctor outside the clinic can help when cost or risk is high.

Read the full fee, later visits, and refund terms at home. You don't have to decide while staff wait for payment. The treatment should still make sense after the sales talk ends.

Evidence sources

1. 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.

2. 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.

3. FDA's final guidance for industry, issued July 2020 by CBER and CDRH under docket FDA-2017-D-6146, sets out how the agency applies the minimal manipulation and homologous use criteria that determine whether a cell or tissue product is a 361 HCT/P or an unapproved 351 biological product requiring a license.

   US Food and Drug Administration, CBER and CDRH — 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. , 2020.

4. 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.

5. On 2 June 2021 the Eleventh Circuit affirmed an injunction against US Stem Cell Clinic in United States v. US Stem Cell Clinic, LLC, holding the clinic's adipose stem cell procedure fell outside BOTH the same surgical procedure exception and the 361 HCT/P exception - the latter because the clinic intended the cells to perform functions beyond the basic functions they performed before the procedure, which is the definition of non-homologous use.

   United States Court of Appeals for the Eleventh Circuit — United States v. US Stem Cell Clinic, LLC, No. 19-13276 (11th Cir. June 2, 2021). , 2021.

6. 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.

7. On 18 December 2024 FDA approved RYONCIL (remestemcel-L-rknd), the first mesenchymal stromal cell therapy ever approved in the United States - for steroid-refractory acute graft-versus-host disease in pediatric patients 2 months and older, given as eight intravenous infusions. It is not an orthopedic product and does not make any joint injection approved.

   US Food and Drug Administration — FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease. , 2024.