NYSCF comments on stem cell tourism regulation

The New York Stem Cell Foundation has commented on the FDA Commissioner's recent statement on stem cell clinics.

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The Food and Drug Administration (FDA) announced an increase in oversight and enforcement of the use of unproven stem cell therapies in the US. Hundreds of clinics around the country provide potentially dangerous or even lethal stem cell therapies to desperate patients. This so-called “stem cell tourism” takes advantage of the critically ill and muddies the results of legitimate stem cell clinical trials.

NYSCF CEO Susan L. Solomon emphasized the importance of this announcement, stating “the regulation of these clinics is very difficult, so the announcement that the FDA will be stepping up their oversight should be welcomed and applauded.” She continued, adding that “there are extremely promising studies and research using stem cells to treat macular degeneration, multiple sclerosis, diabetes and many other devastating diseases. However, anyone advertising a ‘cure’ today is simply taking advantage of patients for their own financial gain.”

Dr. Scott Gottlieb, FDA Commissioner, issued a statement promising additional enforcement in the coming months. Read his statement here.

Source: NYSCF press release

Go to the profile of New York Stem Cell Foundation

New York Stem Cell Foundation

(NYSCF), Non-profit organization

The New York Stem Cell Foundation (NYSCF) combines the depth of a highly focused research institute with the breadth of a wide-ranging philanthropic organization. Since its establishment in 2005, NYSCF has invested over $140 million in stem cell research and continues to conduct the most advanced stem cell research, both in its own laboratory in New York City, and in collaboration with major medical research institutions around the world. By supporting and pursuing only the most advanced stem cell research, as well as through the development of the NYSCF Global Stem Cell ArrayTM, NYSCF serves as a bridge from research to cures.


Go to the profile of James L. Sherley, M.D., Ph.D.

It is unfortunate that the leadership of the NYSCF continues to adopt the disparaging and prejudicial language of "stem cell tourism" when referring to private stem cell clinics as a group.  These self-promoting pronouncements are not productive towards achieving the full range of available strategies for advancing safe and efficacious  stem cell medicine.   This statement from the NYSCF greatly distorts the recent balanced and well-informed  statement from FDA Commissioner Gottlieb, which while acknowledging that "bad actors" exist in the delivery of current stem cell treatments, they are neither all of private stem cell clinics nor do they exist only in private stem cell clinics.   The best progress in stem cell medicine will be made with data-informed, unprejudiced, balanced policies that apply to all cases of experimental stem cell treatments, whether in private clinics or in FDA-regulated clinical trials.  But if attitudes and motivations like those expressed by the NYSCF maintain as they have, we will greatly under-serve patients who are in dire need of new transformative treatments, for which stem cell therapy may be one path to achieving.

James L. Sherley, M.D., Ph.D.

Director,  Asymmetrex, LLC