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Jun 21, 2021

FDA Patient and Consumer Alert - Avoid Stem Cell Bad Actors

Boston Sports & Biologics Remains Compliant with FDA Guidelines

The U.S. Food & Drug Administration (FDA) has published another Consumer Alert on regenerative medicine therapies. On June 3, 2021, the FDA published an alert warning patients and consumers about unapproved products and potential side effects following these treatments.

Boston Sports & Biologics remains compliant with FDA guidelines for orthobiologics.

FDA Role in Protecting Patients and Consumers

Like other medical products, the Food and Drug Administration (FDA) oversees and regulates regenerative medicine and stem cell therapy treatments. In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy “hype.”

A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. At this time the FDA has not approved any stem cell-based products for use other than cord blood-derived blood-forming stem cells for certain blood diseases, and many treatments are still only in early investigatory stages. At Boston Sports & Biologics, we recognize the FDA’s important role in assuring patient safety.

Boston Sports & Biologics remains compliant with FDA guidelines for orthobiologics, and does not make claims that these treatments off a cure for any condition, disease or injury. These regenerative treatments are meant to help with pain and function; however, the practice of medicine and surgery is not an exact science and no guarantees can be made concerning the results of any regenerative procedure as results can vary.

Boston Sports & Biologics Remains Compliant with FDA Guidelines

The procedures offered by Boston Sports & Biologics remain compliant with the 2017 FDA Guidance Document on Regulatory Consderations for Human Cells, Tissues, and Ceullular and Tissue-Based Products: Minimal Manipulation and Homologous Use. All of the procedures performed at Boston Sports & Biologics use 501(k) FDA cleared devices and are consistent with the minimal manipulation and homologous use criteria outline by the FDA. Procedures offered by Boston Sports & Biologics include:

  • Platelet-rich plasma (PRP) and blood products
  • Bone marrow concentrate (BMC, BMAC, stem cells from bone marrow)
  • Lipogems Fat/Adipose grafts (Micro-fragmented fat, MFAT)

Procedures using these regenerative and orthobiologic products are autologous, minimally invasive and treatments are performed consistent with homologous use for orthopedic and sports medicine indications. These orthobiologic procedures are the most studied within the regenerative medicine space. These procedures have not been FDA approved for tendons, ligaments, cartilage, joints, or muscles, but the procedures offered by Boston Sports & Biologics are based on “firm scientific rational and on sound medical evidence” and consistent with FDA guidelines. The use of PRP, BMAC and MFAT have the most safety data behind their use, and are generally considered accepted practices. These procedures are the most studied procedures within the regenerative medicine space, and at Boston Sports & Biologics we only perform procedures based on “firm scientific rational and on sound medical evidence.”

FDA Regenerative Medicine Consumer Alert

The recent Consumer Alert is one of many public warnings and letters issued by the FDA over the past few years. The recent letter listed specific regenerative procedures that the FDA notes are unapproved products. Boston Sports & Biologics does NOT offer these procedures. These procedures include:

  • stromal vascular fraction (fat-derived cells)
  • umbilical cord blood and/or cord blood stem cells
  • amniotic fluid
  • Wharton’s jelly
  • Exosomes

The warning lists stem cells and ortho-biologics, and Boston Sports & Biologics does not perform the specific procedures listed out by the FDA in this recent letter. Boston Sports & Biologics continues to practice within the guidelines set forth by the 2017 document on Regulatory Consderations for Human Cells, Tissues, and Ceullular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

Advice for Patients

The continued focus of the FDA on “bad actors” in the regenerative medicine space will hopefully help patients and consumer navigate this space and find appropriate care for their underlying orthopedic or sports medicine injury.

It is important to understand what treatment you are receiving, and going to a physician who can discuss the current scientific evidence and treatment rational is important. Many of the products outlined in the FDA guidance do NOT contain live cells and if you are being offered amniotic or birth tissue injections as stem cell injections this is clearly false, and may even be illegal. A number of studies have shown that amniotic fluid products do not contain live stem cells (Fortier et al. 2021; Panero et al. 2019). When amniotic tissue is processed it is frozen or dried killing these cells. In Panero et al.’s paper they compared commercially available amniotic fluid samples to samples using bone marrow aspirates the amniotic products did not find living stem cells. In comparision, the bone marrow aspirate culture did show live bone marrow derived stem cells or mesenchymal stem cells (MSCs) or mesenchymal signaling cells.

While amniotic fluid products (AFPs) are not approved, these may have future orthopedic indications. As noted in Panero et al. “(g)iven their growth factor content, however, AFPs may still represent a promising tool for orthopaedic treatment.”

Finding the Right Clinic

At Boston Sports & Biologics all of our treatment protocols are compliant with the published FDA guidance using minimal manipulation, homologous use and firm scientific rational/sound medical evidence. All of the commercial systems we use to process autologous cellular products for our platelet rich plasma (PRP), bone marrow concentrate and Lipogems procedures have received 501(k) FDA-clearance to assure purity and potency. We do not culture cells and do not offer amniotic or birth tissue injections.

Dr. Sussman uses ultrasound and differential injections to confirm the location of the shoulder pain. Dr. Sussman is one of the few physicians in Massachusetts to hold a RMSK certification in musculoskeletal ultrasound and an editor for the Atlas of Interventional Orthopedic Procedures text book that teaches physicians how to perform orthobiologic procedures and interventional injections. Regenerative medicine is a new field and successful placement of these injections into the tendon or joint that matters. Make sure you confirm that your physician is adequately trained to perform these procedures ethically and legally within the FDA guidelines.


Contact Us At:

info@BSBortho.com

P: (781) 591-7855

20 Walnut St. Suite 14

Wellesley MA 02481


REFERENCES:

  1. FDA. Important Patient and Consumer Information About Regenerative Medicine Therapies. Retrieved from https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies (June 21, 2021).
  2. FDA. Regulatory Consderations for Human Cells, Tissues, and Ceullular and Tissue-Based Products: Minimal Manipulation and Homologous Use. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal (June 21, 2021).
  3. Fortier LA, Cercone M, Keller LE, Delco ML, Becktell L, Wells KV. Amnion and Umbilical Cord-Derived Products in Sports Medicine: From Basic Science to Clinical Application. Am J Sports Med. 2021 Jun;49(7):1954-1961.
  4. Panero AJ, Hirahara AM, Andersen WJ, Rothenberg J, Fierro F. 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 Apr;47(5):1230-1235.

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