What does cellular therapy mean in a clinic?

Is bone marrow aspirate concentrate simply marrow that is drawn and spun?

PRP means platelets taken from your own blood and gathered by spinning it. Platelets help blood clot and carry substances your body uses while healing.

Concentrated PRP begins the same way but gathers a higher share of platelets. That difference doesn't promise that your soreness will ease.

For the marrow choice, marrow is drawn from bone and spun that day. A cell count only tells how many cells were found, not whether the joint will feel better.

What will happen during the office visit?

The person examining you first checks where you're sore and how the joint moves. You'll also discuss past care, medicines, and daily limits.

If blood or marrow will be used, ask who collects and prepares it. Find out what you'll feel that day and during recovery.

The office also needs to explain warning signs and after-hours help. If those instructions aren't clear beforehand, don't rush your decision.

What can no one tell me for sure?

No name on a treatment can promise lasting relief. Even people with similar X-rays may feel quite different afterward.

Before care, agree on what better would mean for you. Walking farther, sleeping longer, or using stairs more easily are sensible measures.

Here's what matters most: possible relief comes with real cost and recovery. Take your time because nobody else can weigh those for you.

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. 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. 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.

4. 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.

5. 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.

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.

7. 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.