What to ask about the treatment itself

What bone marrow aspirate concentrate means: drawn and spun marrow

BMAC is the short name for bone marrow aspirate concentrate, or marrow drawn through a needle and then spun. The clinic keeps a thicker liquid with blood cells, platelets, and other cells. Platelets are small blood parts that help stop bleeding. No single kind of cell is separated and measured by itself.

Two prepared samples may contain different amounts of each part. Ask where the marrow is drawn and which liquid is kept after spinning. Then ask why the clinician thinks that mixture fits your joint. The written name confirms which treatment the office means.

What to ask about a blood-based option

For blood-based care, PRP means platelet-rich plasma made by drawing and spinning your blood to gather the platelets. The prepared plasma is used near the sore joint. Concentrated PRP contains more platelets than the standard form. More platelets don't tell you whether soreness will ease or whether risk changes.

Ask which form the clinician plans to use and why. Your exam, earlier care, and daily trouble still guide the choice. Find out how many days your normal tasks may change. Also ask when you can safely return to usual activity.

When to pause over donated material

Donated birth tissue comes from tissue given after another person's childbirth, not from your body. An exosome is a tiny packet released by a cell. Cells use these packets to pass chemical instructions, but an exosome isn't a cell. Sellers may offer products said to contain these packets for sore joints.

Ask who made the product and what the container holds. Handling means where it was stored and each step used to prepare it. A safety check can include a written sterility record showing tests for germs. If staff can't supply these facts, don't agree that day.

Sources

1. 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.

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. FDA's public safety notification of 6 December 2019 states there are currently no FDA-approved exosome products, describes multiple reports of serious adverse events in Nebraska patients treated with unapproved products marketed as containing exosomes, and rejects the claim made by some clinics that exosomes fall outside drug and biological product regulation as 'simply untrue'.

   US Food and Drug Administration, Center for Biologics Evaluation and Research — Public Safety Notification on Exosome Products. , 2019.

5. A CDC Notes from the Field report in MMWR documented infections in US patients during 2018 after receipt of bacterially contaminated umbilical cord blood-derived products used for indications other than blood or immune reconstitution.

   Perkins KM, et al. — Notes from the Field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood-Derived Stem Cell Products for Other Than Hematopoietic or Immunologic Reconstitution - United States, 2018. MMWR Morb Mortal Wkly Rep, 2018. DOI: 10.15585/mmwr.mm6750a5.