At the Institute for Stem Cell and Regenerative Medicine (ISCRM), researchers are excited and optimistic about the use of stem cells to treat human disease. These special cells provide great promise for creating regenerative therapies where currently none exist. ISCRM scientists are working to develop new approaches to today’s most serious conditions and diseases.

Right now, the bone marrow transplant remains the only FDA approved stem cell treatment available at this time. It involves the use of blood stem cells and umbilical cord stem cells to treat individuals with blood cancers such as leukemia. It took decades to develop and demonstrate the safety and efficacy of this procedure.  While ISCRM scientists and researchers are on the brink of new discoveries that may soon change how we confront chronic diseases impacting the heart, brain, kidneys, and pancreas, we want to caution the public to be aware of the current limits of stem cell medicine. Please read more below.

Stem Cell “Clinics” In the News (Cautionary Articles) 

In the hands of responsible scientists, stem cells are powerful tools of discovery and, in some cases, treatment. But, consumers should be extremely wary of predatory “clinics” selling unapproved and unsafe stem cell therapies. Learn more in this February 2019 investigation by KIRO7News.

12 People Hospitalized With Infections From Stem Cell Shots
(The New York Times, December 21, 2018)

FDA Press Release about warning to company marketing dangerous, unapproved stem cell products (December 20, 2018)

Miracle cures of modern quackery? Stem cell clinics multiply, with heartbreaking results for some patients.
(The Washington Post, April 29, 2018)

The Trouble With Stem Cell Therapy
(Consumer Reports, January 11th, 2018)

A Word of Caution on
“Stem Cell Clinics”

We must caution the consumer to be wary of “clinics” that promise to deliver curative stem cell therapies, and to exercise extreme caution when considering enrollment in a clinical trial being offered by a “stem cell clinic.” It falls to the consumer to investigate whether the clinical trial is being conducted with FDA oversight, or whether a “therapy” accompanied by numerous testimonials has been scientifically proven safe, effective, and FDA-approved.

Fortunately, oversight of “stem cell clinics” is increasing. On Thursday, March 22, Governor Inslee signed into law House Bill 2356. This legislation will require Washington State “stem-cell clinics” to post a visible notice that their injection procedures are not FDA-approved and that patients should consult with primary-care providers before undergoing one.

At this point in time only a few FDA-approved stem cell-based treatments are available. One such treatment is the use of blood stem cells and umbilical cord stem cells to treat and even cure individuals with blood cancers such as leukemia.

The methodology used by most of the “stem cell clinics” currently advertising available therapies is to remove adult stem cells from one part of a person’s body, minimally process the cells, and then inject the cells into another part of their body. This use of adult stem cells has never been vigorously tested. It has never been demonstrated to be safe or even effective. These widely-advertised “clinics” are able to circumvent the FDA because they minimally manipulate the cells, a regulatory loophole that enables them to offer this “treatment” without regulatory oversight.

A highly publicized article in the New England Journal of Medicine reported cases of severe vision loss in patients with macular degeneration who had received injections of their own adipose stem cells into their eyes. *The injections were conducted by a Florida “stem cell clinic” under the auspices of a clinical trial that had not been reviewed by the FDA.

Take care of yourself!