FDA Clearance of New Embryonic Stem Cell Clinical Trials and Upcoming Arguments in Federal Court of Appeals

Nov 24, 2010   

Earlier this week, the U.S. Food and Drug Administration (FDA) cleared a human clinical trial using embryonic stem cells. This clinical trial will examine the effects of the stem cells on a rare disease causing serious vision loss, Stargardts Macular Dystrophy. The approval of the trial marked only the second time human trials involving embryonic stem cells have been cleared by the U.S. government.

The California biotech company, Advanced Cell Technology (ACT), expects to begin the research in early 2011. The ACT announcement follows just months after the approval by the FDA of Geron Corp.s clinical trials of a treatment for spinal cord injuries through the injection of cells derived from embryonic stem cells. Our original report on the August approval of the Geron Corp. trials can be found here.

The timing of the FDA clearance of these clinical trials coincides with the ongoing law suit in the U.S. Court of Appeals for the D.C. Circuit regarding federal funding of human embryonic stem cell research. In that case, Sherley v. Sebelius, former MIT professor James L. Sherley is suing the National Institutes of Health alleging that embryonic stem cell research violates federal law. The federal district court had issued a preliminary injunction in the case blocking federally-funded human embryonic stem cell research, but the appeals court temporarily blocked that injunction pending the outcome in the case. Oral arguments are to take place in that case next month.

With the FDA clearance of these embryonic stem cell trials, the Department of Justices fight against government funding of human embryonic stem cell research, and the on-going controversy surrounding stem cell research and lack of clear government regulation or policy on the industry, it seems like the embryonic stem cell debate could be reaching a boiling point.

This week, John Gearhart, head of the University of Pennsylvania’s Institute for Regenerative Medicine and one of the first two scientists to isolate human embryonic stem cells, told the Philadelphia Inquirer that a clear policy on the subject is required. “We need a comprehensive national policy on all human embryo research with appropriate, unequivocal laws,” he said last week. “Congress has no stomach to take this up.” Click here to read the Philadelphia Inquirer article.

Fuerst Ittleman is watching these developments with a keen eye. As a firm with a practice area dedicated to the legal issues surrounding human cellular tissue-based products (HCT/Ps), and as frequent contributors to the debate on the use of adult stem cells, we are anxious to see how the legal issues surrounding the use of embryonic stem cells play out.

For more information on Fuerst Ittlemans experience handling the FDA regulatory framework regarding stem cells, drugs, and biologics, please contact us at contact@fidjlaw.com.