What to ask when a clinic says stem cell therapy

What to know before choosing bone marrow aspirate concentrate

The name is harder than the idea. With bone marrow aspirate concentrate, the clinic removes liquid marrow near your hip and spins it during the visit.

Aspirate means taking the marrow out. Concentrate means spinning keeps a smaller part that contains more of the marrow's cells.

The finished liquid is put in the sore joint. It can differ from one person's marrow to another, so get the exact name of what the clinic will use.

What to ask about the marrow draw

Ask who'll draw the marrow through the skin near your hip. Find out if a doctor, nurse practitioner or physician assistant will do it, then ask about that person's training.

Make sure the clinic knows about blood thinners and past bleeding. Keep taking each medicine until whoever prescribed it tells you to change.

Ask how pressure, soreness and a clean draw area are handled. You'll need those answers before agreeing to the marrow draw.

What QC Kinetix may discuss with you

For QC Kinetix, regenerative treatments is the broad name for non-surgical options that begin with blood or other material from you. A medical provider is whoever checks your joint and gives the care; ask what title and training that person has.

PRP is a blood-based option, and the initials mean platelet-rich plasma. Staff draw some blood, spin it to collect the platelet-rich liquid and then put that liquid in the sore joint.

Blood is the source for PRP; the source for marrow concentrate is your pelvis. Make sure the written treatment name matches what you discussed.

What to get in writing before you agree

Get one written price for the treatment and follow-up. Ask whether another office visit brings another charge.

Have the clinic write down the treatment name and where its material comes from. You shouldn't have to recall a sales talk later.

Get the care instructions before paying. They need to cover walking, driving, expected soreness and whom to call for fever, spreading redness or worse pain.

Take the paperwork home. A sound decision can wait long enough for you to read it and ask more questions.

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. 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.

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. A phase IIb double-blind randomized trial of just 24 knees reported WOMAC improvement at 6 months after a single autologous adipose-derived MSC injection while saline controls did not improve - a positive but very small trial, of the kind that dominates this literature.

   Lee WS, et al. — Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Transl Med, 2019. DOI: 10.1002/sctm.18-0122.

6. A controlled randomized phase I/II trial in 26 patients found repeated dosing of culture-expanded umbilical cord-derived MSCs at baseline and 6 months produced lower WOMAC pain at 12 months (1.1 +/- 1.3) than hyaluronic acid (4.3 +/- 3.5), while a single MSC dose did not separate from hyaluronic acid.

   Matas J, et al. — Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med, 2019. DOI: 10.1002/sctm.18-0053.