The U.S. Food and Drug Administration has issued a warning letter to StemGenex of San Diego after an investigation found its cellular therapy does not conform with good manufacturing practice requirements, is being illegally marketed to treat conditions for which it has not been proven safe or effective, and is putting patients at risk…

In mid-September, the U.S. Senate debated and passed a spending bill that included an increase in funding for the Department of Health and Human Services. The bill did not include a ban on federal funding for fetal tissue research, a measure the ISSCR opposed in a letter to leaders of the U.S. House and Senate, signed by 64 organizations.

The ISSCR is troubled by the recent decision by the U.S. Department of Health and Human Services to “conduct a comprehensive review of all fetal tissue research.” The directive appears to come after intensive lobbying efforts by special interest groups with the goals of delaying or curtailing scientific research that relies on fetal tissue. Fetal tissue research has been necessary for the development of vaccines and therapies that have saved millions of lives, and continues to be important for the future of medicine. Decisions about how best to conduct research and to advance human health should be based on science and medicine, not ideology or politics.

The ISSCR, the largest professional organization of stem cell researchers from around the world, opposes the U.S. House of Representatives proposal to ban federal funding for fetal tissue research. ISSCR President Hans Clevers released the following statement…

The ISSCR is disappointed with the enactment of the ‘Right to Try’ law. Along with more than 100 patient and research groups opposing the bill, we believe it will put patients at risk and undermine the effective FDA Expanded Access Program already in place to give seriously ill patients access to experimental treatments.