Stem Cell Therapeutics: When will they be ready?
Today’s news of a dozen people needing hospitalization after receiving stem cell therapies that were not in a clinical trial or FDA approved brings into sharp relief the challenges faced by Stem Cell and Regenerative Medicine Institutes and Centers around the United States:
https://www.nytimes.com/2018/12/20/health/stem-cell-shots-bacteria-fda.html
Weekly, I am told about someone who has had, or knows someone who has had, stem cells of unclear types or from unclear sources injected into them, with a positive report. Unfortunately, virtually all of such studies are done with ill-defined material, with an unknown mechanism of action, and without a placebo control. The question is whether people would feel better if they were injected with a neutral substance, but told that they were injected with stem cells. And as the news report of today indicates, the lack of proper medical controls on the methodology can lead to illness or worse.
A first principle of medical ethics is to do no harm. The same goes for stem cell research. We, at the Institute for Regenerative Medicine at UPenn, and my colleagues at Stem Cell and Regenerative Medicine Institutes allied with established research universities and medical centers around the world, promise safety in our products and rigor in our analysis. And we are working on remarkable therapies and cures; but it will take time and carefully designed studies to be sure of safety first, then efficacy- how well does it work?
In the meantime, rest assured that weekly we hear about remarkable and genuine advances from stem cell technologies. Tissues and organs can now be reconstituted from different stem cell products and from different human genetic backgrounds, allowing us to reconstitute “diseases in a dish” to discover diagnostics, new drugs, and eventually, cell therapeutics.
We need your investment and we need your participation (https://irm.med.upenn.edu/giving-opportunities/). Be very careful about participating in any purported stem cell therapy that is not a part of a clinical trial or FDA approved. Our field is moving at an incredible pace, and we want you to be part of its future.
Best wishes for the holidays and the new year,
Ken Zaret
Director, IRM