What could the clinic put into my joint?

What does PRP mean?

A small blood sample is the starting point for PRP. The clinic spins it in a machine, separating the blood and saving liquid with many platelets, the tiny blood pieces that help form clots and release substances used while healing.

Standard PRP and concentrated PRP both start with your blood, but the concentrated version puts more platelets into the final liquid. That changes its contents; it doesn't promise greater relief.

Ask which version would be used and why it fits your joint.

What is bone marrow aspirate concentrate?

Bone marrow aspirate concentrate starts with liquid marrow drawn through a needle from the pelvis, and the word aspirate simply means the liquid that comes out through that needle. A machine spins the marrow, takes away some watery fluid, and leaves a smaller portion containing marrow cells and platelets.

That final portion is a mix, not one special kind of cell, and its contents differ between people. Clinics may also collect and spin marrow in different ways.

Ask what will be removed, what will be saved, and whether it enters the joint that day.

Could either liquid rebuild the joint?

Platelets and marrow cells release chemical messages during the body's normal healing work. Because those messages may affect swelling and soreness, researchers have studied these treatments. Human studies haven't proved that a clinic's blood or marrow liquid rebuilds worn cartilage, the slick layer that caps each bone end.

Less aching isn't the same as growing a new joint surface, since movement may improve without new cartilage forming. Ask whether the clinic expects symptom relief or a change visible on a test.

If the answer sounds certain, ask what happened in people with the same sore joint.

Sources

1. In 96 patients, concentrated bone marrow aspirate contained a mean of 26.3 million nucleated cells per mL but only about 1,422 colony-forming units of connective tissue progenitors, and the nucleated cell count had negligible predictive value for how many progenitor cells were actually present (r-squared 0.28).

   Muench LN, et al. — Nucleated Cell Count Has Negligible Predictive Value for the Number of Colony-Forming Units for Connective Tissue Progenitor Cells (Stem Cells) in Bone Marrow Aspirate Harvested From the Proximal Humerus During Arthroscopic Rotator Cuff Repair. Arthroscopy, 2021. DOI: 10.1016/j.arthro.2021.01.064.

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. 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.

4. 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.

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. 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. 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.