The study involves administration of a single or multiple doses of MultiStem, an allogeneic cell therapy product, to patients following radiation therapy and a donor derived hematopoietic stem cell transplant.
- The Phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of a single or multiple dose administration of allogeneic MultiStem delivered intravenously following standard allogeneic hematopoietic stem cell transplant;
- Patients enrolled in the study receive either a low, medium or high dose of MultiStem, and are being evaluated against current standard of care;
- Treatment of the final patient for the single dose arm occurred 12/30/10, consistent with the previously stated goal of completing enrollment prior to year-end, while enrollment in the multiple dose arm will continue and is intended to be completed in 2011;
- The study is being conducted at multiple bone marrow transplant centers in the US, including Oregon Health & Science University Medical Center, Texas Transplant Institute, University Hospitals Case Medical Center, University of Pennsylvania, Mayo Clinic Arizona and several other sites;
- Patients receiving such transplants are typically at risk for Graft-Versus-Host Disease (GVHD), as well as other complications, such as tissue damage from the radiation and chemotherapy treatments that are conducted prior to the transplant;
- Initial results of safety information from the single dose arm of this trial are expected to be announced following the completion of patient evaluation periods and subsequent analysis of data.