FDANews

FDA ALLOWS VIACELL'S CB001 STUDY TO RESUME

ViaCell has announced that federal regulators have allowed the company to resume clinical testing of a stem cell product aimed at treating cancer, three months after they put testing on hold. The FDA lifted its clinical hold on its study of CB001, a stem cell product for potential use in stem cell transplantation in various cancers to provide regeneration of blood and immune systems.

So far, CB001 has been given to eight of ten patients in the study. CB001 consists of a highly enriched population of hematopoietic stem cells that are selectively amplified from umbilical cord blood.