Gene-Therapy Trials at Penn Being Revised
PHILADELPHIA -- The University of Pennsylvania said yesterday it will dramatically restructure its Institute for Human Gene Therapy in the wake of patient-safety concerns raised by the death of an Arizona man during a clinical trial last fall.
The changes, prompted by an in-depth review of Penn's institute by an outside scientific committee, were hailed by the U.S. Food and Drug Administration, which has put a hold on all of Penn's human gene-therapy trials since the death of Jesse Gelsinger.
In a brief statement, however, FDA officials gave no hint of whether the changes would be enough to lift the freeze on gene-therapy experiments aimed at curing various inherited disorders and cancers.
Penn's restructuring, which is likely to prompt similar changes at other universities, comes as the experimental field of gene therapy is beginning to show its first successes. Preliminary evidence of cures were recently reported in France and at Children's Hospital of Philadelphia.
But as September's gene-therapy death at Penn illustrated, the fledgling field still faces a host of safety and ethical concerns -- issues that Penn, other universities, federal health agencies and Congress are now trying to address. …