“Good Actors” in Regenerative Medicine

Published by Michael Tierney

June 16, 2020

The power of regenerative medicine to heal, and prevent, a broad range of diseases and conditions has been recognized by major governments and medical institutions around the world. Already fifteen years ago, the U.S. Department of Health and Human Services stated:

“Regenerative medicine is the next evolution of medical treatments. Derived from the fields of tissue engineering, tissue science, biology, biochemistry, physics, chemistry, applied engineering and other fields, regenerative medicine is the first truly interdisciplinary field that utilizes and brings together nearly every field in science. This new field holds the realistic promise of regenerating damaged tissues and organs in vivo (in the living body) through reparative techniques that stimulate previously irreparable organs into healing themselves. Regenerative medicine also empowers scientists to grow tissues and organs in vitro (in the laboratory) and safely implant them when the body is unable to be prompted into healing itself.

This revolutionary technology has the potential to develop therapies for previously untreatable diseases and conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis and spinal cord injuries. Virtually any disease that results from malfunctioning, damaged, or failing tissues may be potentially cured through regenerative medicine therapies. Having these tissues available to treat sick patients creates the concept of “tissues for life.”‘ [1]

The U.S. Department of Defense invests heavily in regenerative medicine, as does California, New York and dozens of other public sector entities. [2] In a seminal paper published in the New England Journal of medicine, Scott Gottlieb, the former commissioner of the Food and Drug Administration, stressed the potential power of regenerative medicine:

“Scientific advances have shown us that stem cells are indeed remarkably complex biologic entities. To complicate matters, the term “stem cells” has been used to describe a variety of cells that have the capacity to divide and differentiate, including hematopoietic stem cells and adipose-derived stem cells (mesenchymal stem cells). The potential benefits to human health have spurred major progress in stem-cell biology over the past several decades. The field has moved from characterization of the properties of these cells toward therapeutic applications.”

In that same paper, however, Commissioner Gottlieb drew a sharp line between the “good actors” and the “bad actors” in the field.

“Even in the absence of serious adverse events, the use of therapies that are of unproven efficacy is a disservice to patients and to public health. An increasing number of safe and effective therapies are becoming available on the basis of the findings of well-designed clinical trials. It is critical to focus on efforts to facilitate the development of such therapies, rather than propagating products with dubious clinical efficacy and possible risks.” [3]

Unfortunately for most consumers and patients, it is difficult to distinguish between the “good” and the “bad” actors. As pointed out in a Scientific American article:

“Advertisements and pseudo news articles promote stem cell treatments for everything from Alzheimer’s disease, autism and ALS, to cerebral palsy and other diseases. The claims simply aren’t true–they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public. Patients and their families can be misled by deceptive marketing from unqualified physicians who often don’t have appropriate medical credentials and offer no scientific evidence of their claims. In many cases, the cells being utilized are not even true stem cells.” [4]

In short, bad actors are those product manufacturers or healthcare professionals who make claims about their products or services which are not supported by the evidence. A recent medical journal article found that 96% of online marketing by cell therapy centers contained at least one false or misleading claim. [5] In most instances, the consequences for a patient may be overspending – often unjustifiably large amounts — on a treatment which has no lasting benefit. In other cases, however, unsupported “cell therapy” – especially when coupled with improperly trained clinicians — lead to serious injury. [6] Both the F.D.A. and the state attorneys general are initiating enforcement actions against unscrupulous bad actors”.

Conversely, “good actors” understand the scientific basis for the immunomodulatory, regenerative and reparative capabilities of the human body. They also understand where there is insufficient evidence to support a particular clinical claim or procedure. Equally important, such good actors are committed to clinical excellence in the diagnosis and delivery of a given regenerative medicine intervention, ongoing engagement with the patient throughout the clinical journey, and the collection and transparent patient communication of science-based evidence relating to each procedure.

Regen Med has long helped practitioners, institutions and healthcare manufacturers achieve and maintain Good Actor status within Federal, State and EU regulatory environments. If you’re interested in learning more about our services or success stories, please contact us at info@rgnmed.com. Additional resources are provided below for convenience.

[1] The full HHS report can be found here.

[2] See for example the Armed Forces Institute of Regenerative Medicine, the California Institute for Regenerative Medicine, the Wake Forest Institute for Regenerative Medicine and New York State Stem Cell Science, to name only a few.

[3] The full NEJM article can be found here.

[4] The full article can be found here.

[5] Journal of Bone and Joint Surgery, January 2, 2020. See here. See also this article in the Bone and Joint Journal.

[6] See this article discussing how three women went blind after receiving a “stem cell” treatment at a Florida center.

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