Some soreness can wait, and some cannot

A hot, swollen joint needs quick care

Fever plus joint heat calls for prompt care. Call now if you can’t stand or walk. A sudden change isn’t a routine clinic matter.

New numbness or weakness can be urgent. It shouldn’t wait until tomorrow. Tell the person answering exactly what changed and how quickly.

Watch the procedure spot after treatment. Don’t ignore spreading redness or thick, cloudy fluid. New calf swelling may mean a blood clot.

Your health can change procedure risks

Tell the team about blood thinners. An active infection may delay a joint procedure. Cancer treatment may change whether or when it’s safe.

Drawing blood or marrow can cause bleeding. Infection or nerve injury can also happen. That doesn’t mean you’ll have these problems.

Ask who handles trouble after treatment. Get the clinic’s hours and phone number. You’ll need clear steps for urgent care.

You can refuse a procedure

The team will examine your sore joint. They’ll ask what limits your day. You don’t have to accept a procedure.

Ask why the procedure fits your joint. Get the risks and total cost in writing. There’s another choice if it doesn’t help.

Note any night soreness or new swelling. Bring your medicines and earlier reports. That’ll help the team answer your questions.

Sources

1. A retrospective comparison of 523 bone marrow aspiration procedures against 435 open iliac crest bone graft harvests found aspiration significantly reduced complications - relevant because marrow aspiration for a joint injection is a real procedure with a real, if low, complication rate.

   Hernigou P, et al. — Morbidity of graft harvesting versus bone marrow aspiration in cell regenerative therapy. Int Orthop, 2014. DOI: 10.1007/s00264-014-2318-x.

2. A CDC public health investigation confirmed culture-positive bacterial infections in 20 patients who received umbilical cord blood-derived products marketed as stem cell treatment between August 2017 and September 2018; whole-genome sequencing matched patient isolates to the product.

   Hartnett KP, et al. — Investigation of Bacterial Infections Among Patients Treated With Umbilical Cord Blood-Derived Products Marketed as Stem Cell Therapies. JAMA Netw Open, 2021. DOI: 10.1001/jamanetworkopen.2021.28615.

3. A laboratory study of three commercially available amniotic fluid products marketed for orthopedic use found no viable mesenchymal stem cells in any of them when compared against unprocessed amniotic fluid and bone marrow-derived MSC samples - products sold as 'amniotic stem cell therapy' contained no living stem cells.

   Panero AJ, et al. — Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. Am J Sports Med, 2019. DOI: 10.1177/0363546519829034.

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. 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.

6. 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.