FDA Panel Weighs Guidelines For Human Clinical Trials Involving Treatments From Embryonic Stem Cells

Main Category: Stem Cell Research
Also Included In: Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 15 Apr 2008 - 8:00 PDT

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Because of the potential risks involved in human embryonic stem cells, data on the effectiveness of treatments using them "may need to be particularly strong," Steven Bauer, chief of FDA's cell and tissue therapy branch, said in a presentation to the FDA advisory panel examining how the agency will regulate human clinical trials using treatments derived from embryonic stem cells, Dow Jones reports. Bauer expressed concerns that the cells can cause malignant tumors and other risks, as tests in animals have shown that embryonic stem cells can cause benign tumors.

Bauer presented information before an FDA advisory panel that is examining how the agency will regulate human clinical trials using treatments derived from embryonic stem cells. According to Bauer, it is possible FDA will require companies to show stem cell treatments are effective during early Phase I trials. Usually, Phase I trials only test proof-of-concept and look at potential safety issues. They generally are not designed to show whether a product works, according to Dow Jones.

At the hearing, Jane Lebkowski, senior vice president of regenerative medicine at Geron, said FDA also needs to consider whether drugs that suppress the immune system will be needed for the body to accept stem cells, and, if so, for how long. Geron plans to file an FDA application this summer to begin human testing of a therapy to repair acute spinal injury (Corbett Dooren, Dow Jones, 4/10).

German Parliament Approves Loosening Restrictions on Imported Stem Cells

In other stem cell news, the German Parliament on Friday loosened restrictions on which embryonic stem cells researchers can use, the AP/International Herald Tribune reports. A 2002 law had banned the creation of embryonic stem cells within the country for research purposes and prohibited stem cells produced abroad after Jan. 1, 2002, from being imported into the country. Under the new law -- which was approved 346-228 with six abstentions -- researchers will be able to use imported stem cells created before May 1, 2007 (AP/International Herald Tribune, 4/11).

According to Reuters, the law was changed following scientists' complaints that the restrictions prevented them from keeping pace with stem cell research in other countries. Some researchers had called for the restrictions to be eliminated completely, Reuters reports (Gehmlich, Reuters, 4/11).

German Chancellor Angela Merkel, Research Minister Annette Schavan and Justice Minister Brigitte Zypries all advocated for the change, according to the AP/Herald Tribune. Schavan said the "move fits with the law's logic by enabling a further development that makes" the research "possible." Conservative Party member Maria Boehmer argued against the law, saying it "would be judged abroad as a signal that we are prepared to shift the ethical boundary if researchers demand it loudly enough."

The Roman Catholic Church opposed the change, but the country's Lutheran Church supported it, according to the AP/Herald Tribune (AP/International Herald Tribune, 4/11).

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