Stem Cell Tranasplant for Chemo-Radiation Therapy or Chemotherapy Recovery: Phase I Clinical Trial Completed
ViaCell, Inc. today announced that it has enrolled and treated the last patient in the CB001 Phase I clinical trial and has begun the 100-day post-transplant follow-up.
CB001 is an investigational therapy being studied as a potential therapeutic option for people who need stem cell transplants, such as bone marrow, for hematopoietic recovery after chemo-radiation therapy or chemotherapy in the treatment of a variety of blood cancers.
The Phase I clinical trial is a safety study of CB001 using stem cells that have been isolated from umbilical cord blood and expanded using ViaCell’s proprietary expansion technology. Ten patients received treatment in the study. A preliminary data review indicates that there were no infusion toxicity events related to CB001. ViaCell expects to announce
top-line results from the Phase I clinical trial in the fourth quarter of 2006 and, if positive, the Company intends to advance the product into a Phase II clinical trial.
According to the President and CEO of ViaCell, there is an important medical need for patients who are unable to find a suitable bone marrow donor and an expanded umbilical cord blood derived stem cell product has the potential to be a therapeutic alternative.