What happens before and after treatment

Your exam decides whether a procedure fits

Medical providers aren’t all clinic workers. They’re the clinic staff who examine you. They’ll review your health and current medicines.

Tell them about bleeding or past infections. Bring notes on earlier therapy, medicines, and procedures. The team shouldn’t skip that history.

Ask whether the joint, muscle, or bone hurts. Have the team explain its choice plainly. If the reason isn’t clear, keep asking.

PRP starts with blood from your arm

You’ll hear PRP called platelet-rich plasma from your own blood. Platelets are tiny pieces in blood that form clots. Clinic staff spin the blood to separate its parts.

Most red blood cells settle away from the plasma. The clinic keeps plasma with more platelets for treatment. That’s why the spinning step matters.

Concentrated PRP keeps an even larger share of platelets. You’ll still start with blood from your arm. Ask why either kind fits your joint.

Bone marrow concentrate starts at your pelvis

Bone marrow comes from the back of your pelvis. This draw isn’t like taking arm blood. You may feel pressure where staff collect it.

Bone marrow aspirate concentrate means drawn marrow with some fluid removed. Clinic staff don’t keep all the fluid after a machine spins it. They keep a thicker part with blood and marrow cells.

The prepared marrow is then used for your treatment. Ask what soreness is normal afterward. You’ll need the clinic’s urgent phone number before leaving.

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. Mesenchymal stromal cells make up only about 0.001 to 0.01 percent of the nucleated cells in bone marrow, so the harvesting and processing technique - aspiration site, syringe size, centrifuge speed and time - materially determines what ends up in the syringe, and no consensus protocol exists.

   Jeyaraman M, et al. — Impact of the Process Variables on the Yield of Mesenchymal Stromal Cells from Bone Marrow Aspirate Concentrate. Bioengineering (Basel), 2022. DOI: 10.3390/bioengineering9020057.

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. The 2005 International Society for Cellular Therapy statement that first flagged the problem concluded that plastic-adherent marrow cells do not meet generally accepted criteria for stem cell activity, making the name 'mesenchymal stem cell' scientifically inaccurate and potentially misleading to the lay public.

   Horwitz EM, et al. — Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy, 2005. DOI: 10.1080/14653240500319234.

5. 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.

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.

7. 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.

8. A phase III double-blind placebo-controlled trial in 261 patients with Kellgren-Lawrence grade 3 knee osteoarthritis tested a single injection of autologous culture-expanded adipose-derived mesenchymal stem cells - a product that cannot legally be sold outside a clinical trial in the United States because culture expansion is more than minimal manipulation.

   Kim KI, et al. — Clinical Efficacy and Safety of the Intra-articular Injection of Autologous Adipose-Derived Mesenchymal Stem Cells for Knee Osteoarthritis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Sports Med, 2023. DOI: 10.1177/03635465231179223.

9. 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.

10. 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.

11. 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.