What to ask before agreeing to a product

What to ask about the source and preparation

Ask whether the treatment comes from your own blood or marrow. If it came from another person, ask which tissue was donated. Then ask which steps happen in the office that day. Lab-grown cells are different because a lab keeps and grows them.

Ask whether a federal health agency checked that exact product for your joint. A useful reply gives a clear yes or no, then names the product and allowed use. If staff mentions office registration, ask what the registration proves. Registration may only mean the business appears on a federal list; it doesn't show that this joint treatment was checked.

What to do with the written answer

Match the consent form to the treatment name staff wrote down. If the office gives you a study, check its treatment and joint. Different names may mean that the study tested something else. Don't continue until staff explains any difference in plain words.

Take the consent form home when you need more reading time. It should list what goes into your joint, possible harm, follow-up, and other choices. A sale price shouldn't rush a health choice. Keep the papers and discuss them with the doctor who knows your health.

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. 21 CFR 1271.15(b) contains the 'same surgical procedure' exception, which exempts an establishment that removes human cells or tissues from an individual and implants them into the same individual during the same surgical procedure - the provision two federal appeals courts have now held does NOT cover same-day stromal vascular fraction, because what is implanted is not the same as what was removed.

   US Code of Federal Regulations, Title 21 — 21 CFR 1271.15 - Are there any exceptions from the requirements of this part. , 2001.

5. 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.

6. 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.