What material is used for your joint?

What is bone marrow aspirate concentrate?

Bone marrow aspirate concentrate uses marrow taken from your pelvis. The word aspirate means pulling it out through a needle. Concentrate means spinning it so cells gather in less liquid.

The clinic prepares the marrow that day. Some then goes into your sore joint. You'll need care directions for the bone and joint.

What are PRP and concentrated PRP?

Here, PRP refers to platelet-rich plasma. Your blood gets spun so platelets gather in less plasma. That liquid then goes into your sore joint.

Concentrated PRP requires drawing and spinning blood too. Ask how the two methods differ. Don't agree until you understand every step.

What does QC Kinetix offer?

QC Kinetix may offer regenerative treatments and biologic therapies. Both labels can mean preparing your own blood or marrow, then placing the result in a sore joint. The medical provider checks your joint before discussing either choice.

Those labels don't name one procedure. PRP and concentrated PRP start with blood, while marrow care uses a needle in bone. Joint preservation means discussing non-surgical care before knee or hip surgery.

Why does the exact name matter?

Regenerative treatment is a broad clinic label. A useful answer names blood, marrow, or donor tissue. It also says where the prepared liquid will go.

Find out which body part supplies it. Ask who performs each part of the procedure. Don't agree when those answers stay unclear.

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. 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. 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.

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. 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.

6. 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.

7. 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.