Tuesday, September 10, 2013

Stem cell “clinical trials” without published data are not clinical trials, the New York Times weighs in

This morning’s Science Times section of the New York Times has a well written piece that tries to balance the hopes and aspirations of patients in need of therapy today and the questionable practices of many stem cell clinics, particularly those operating in other countries. The “stem cell tourism” associated with those clinics prompted a joint patient advisory signed by CIRM and 12 other organizations last month.

Much of the Times article focuses on one clinic in Mexico where the founder says he is trying to do stem cell clinical trials properly. He says that his clinical trials are registered with the National Library of Medicine and require informed consent. But a U.S. expert of clinical trials quoted in the piece says the informed consents would never pass muster in this country and the clinical trials designs would not get past the institutional bodies that review them here.

Most important, the clinic has not produced any publishable data. We all have great hope for the promise of stem cell science, but I think it is fair to say that anyone who legitimately cares about that promise wants to find out what is the right type of cell to put in each patient. When is the right time for the transplant, and what is the best method of delivering the cells. We will never learn those things without collecting data in a well-designed clinical trial and sharing that data.

Fellow blogger and CIRM grantee, Paul Knoepfler of the University of California Davis is quoted in the article:
“There is absolutely no legitimate reason for such clinics to be not publishing their data. Yet they almost never do.”
The Times notes that later this week the International Society for Stem Cell Research will be releasing a statement on these clinics. It will be posted with their other online materials for patients.

Don Gibbons



1 comment:

  1. The Success to the Clinical trial depends upon the subject Recruitment and Retention but at the same time, successful recruitment of participants for any clinical trial is a challenge.

    ReplyDelete