VIACELL SUSPENDS ENROLLMENT IN PHASE I STUDY
ViaCell has suspended enrollment of an early stage clinical trial testing stem cells as a cancer treatment after some patients had serious adverse reactions.
The treatment, known as CB001, is made up of blood cell-making stem cells harvested from umbilical cord blood. The company suspended the trial after two out the eight enrolled patients experienced Grade IV acute graft-versus-host-disease, the most severe, and often fatal, form of the immune system attacking transplanted cells. ViaCell said both patients recovered from the rejections.
The company needs to examine the cases with the institutional review board for the clinical trial site before it can resume enrolling. The trial had hoped to enroll 10 patients total.