MedShadow Foundation Reports on Two Decades of Research and Regulation of Stem Cell Therapy

In their 4-part editorial series, MedShadow Foundation delves into the history of stem cells.This research has been controversial since it was first brought to public attention. Initially, federal laws limited the use of these cells in research, because they came from fetuses. But over time, those restrictions became less restrictive, especially as scientists found that stem cells could be derived from other sources, like umbilical cord blood rather than directly from the fetus, or even from reservoirs in adults’ bone-marrow and fat tissue.

This series is a timely exploration of the topic concerning upcoming FDA regulations and enforcement. Following the FDA’s first changes in 2017 to their “Framework for the Regulation of Regenerative Medicine Products,” companies have until May 31st, 2021 to adjust to the new regulations. Those procedures had previously fallen into a gray area of regulation because they rely on harvesting live stem cells or related products rather than traditionally manufactured drugs to repair damaged tissues and organs. Starting June 1, the agency expects all such companies to be in compliance or risk a variety of enforcement actions from issuing warning letters to pursuing criminal prosecution.

Regarding this series, an FDA spokesperson tells MedShadow Foundation, “Clinics currently offering products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients.”

Key information:

An analysis of Google Search data shows that interest in stem cell therapies has grown over time. During 2015, searches began picking up dramatically and didn’t start dropping until the Spring of 2020.

When it comes to clinical trials, studies haven’t always been designed in ways that provide definitive answers. Since most treatments aren’t FDA-approved, some providers register studies on clinicaltrials.gov and then offer the treatments to patients as participants of the trials.These stem cell trials may be a sham to imply that the FDA is watching over a company’s work.

Some types of minimally manipulated regenerative medicine are still exempt from much FDA oversight, requiring only that their facilities keep up manufacturing standards that limit contamination. Regulations don’t deter many, as it’s estimated that the US has more regenerative medicine clinics than anywhere else in the world.

Embargoed 5:00 AM (ET) Tuesday 01 June 2021

Access MedShadow’s Regenerative Medicine series below. For access to the first article, please email pr@medshadow.org. For pre-embargo access to Parts 2, 3, and 4, use the following password in parenthesis: (PressAccess202!). 

https://medshadow.org/a-brief-history-of-regenerative-medicine-regenerative-medicine-series/

https://medshadow.org/the-fda-cracks-down-on-stem-cell-therapy/

https://medshadow.org/moving-forward-and-keeping-stem-cell-treatments-safe/

https://medshadow.org/what-if-i-want-a-stem-cell-treatment/

About MedShadow Foundation

MedShadow Foundation is an award-winning, independent, online nonprofit 501(c)(3) that informs people about the side effects, long-term impacts, risks and benefits of medicines, both over-the-counter and prescription. The organization was founded in 2012 by Suzanne Robotti, a health/patient advocate who currently serves as the consumer representative on the FDA Drug Safety and Risk Management Advisory Committee. MedShadow engages leading medical and science journalists to report on news and studies about the side effects of medicines. MedShadow Foundation does not accept any funding or support from pharmaceutical companies or medical device manufacturers. In 2020, the company was once again awarded the prestigious “Top-Rated” designation by Great Nonprofits. For more information, visit https://www.medshadow.org.