What to ask about bone marrow aspirate concentrate

What to ask about the material

Here, aspirate means marrow drawn out, while concentrate means the sample is spun. The finished liquid contains several kinds of cells and other parts of marrow.

The amounts can differ because the preparation method can differ. Ask how your sample would be prepared and what would enter the joint.

A cell count may cover many kinds of cells in the prepared marrow. Ask which cells are counted and why that number matters for your joint.

PRP comes from blood, not marrow. A blood draw comes first, and spinning collects the portion with more platelets.

Platelets are tiny pieces in blood that help it clot. The provider puts the prepared portion, rather than whole blood, into your joint.

Concentrated PRP has more platelets in the same amount of prepared blood. More platelets aren't proof of a better or safer result.

What to do if the joint still aches

Don't choose a procedure from its name alone. First find out whether the joint, a tendon, or nearby muscle is causing the ache.

QC Kinetix calls procedures made from your blood or marrow biologic therapies. The clinic prepares the chosen source and puts the finished liquid in the aching joint.

A medical provider is the person who examines you and performs that procedure; ask whether the person is a doctor. Ask who draws the blood or marrow and who prepares it.

The exam comes first, so your procedure can't be named in advance. Before agreeing, get the exact source and preparation in writing.

Also ask about soreness afterward, help getting home, and follow-up. You don't need every lab term, but you do need those answers.

The main point is concrete: know what leaves your body and what enters your joint. That knowledge lets you compare the offered procedure with other care.

Sources

1. 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.

2. 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.

3. 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.

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. In a prospective randomized trial of 90 patients with Kellgren-Lawrence grade 1-3 knee osteoarthritis, bone marrow aspirate concentrate produced outcomes equivalent to - not better than - leukocyte-rich platelet-rich plasma through 24 months.

   Anz AW, et al. — Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. Am J Sports Med, 2022. DOI: 10.1177/03635465211072554.

6. 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.