ViaCell intends to submit information to the investigational review boards at each study site involved in the phase I trial to request immediate resumption of. To date, CB001 has been administered to eight of ten patients in the study.
CB001 consists of a highly enriched population of hematopoietic stem cells which are selectively amplified from umbilical cord blood.
“Our team did an outstanding job providing the FDA with the information it needed to lift the hold,” stated Marc Beer, president and CEO of ViaCell. “We will now work with our study sites to advance our CB001 clinical program.”
ViaCell is a biotechnology developing a pipeline of proprietary stem cell product candidates intended to address cancer, cardiac disease and diabetes.