Children's Hospital enrolls patients for ExCell clinical study

Children's Hospital of Colorado and the Gamida Cell-Teva Joint Venture announced today that Children's Hospital is enrolling patients for the ExCell study. Children's Hospital is the 24th in a series of cord blood transplant sites worldwide, five of which are children's centers, participating in the study in the U.S., Spain, Italy, Hungary and Israel. The trial is researching the safety and efficacy of StemEx as a therapeutic treatment for patients with blood cancers like leukemia and lymphoma.

StemEx is a graft of blood-forming stem/progenitor cells, derived from a single unit of umbilical cord blood and expanded in culture. The graft is composed of non-embryonic stem cells committed to blood formation. The StemEx product is transplanted in combination with non-expanded cells from the same unit. StemEx is being developed by a Joint Venture of Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: TEVA).

"ExCell is an important trial that gives us an opportunity to investigate alternative treatments for blood cancers. We also think it is important that the medical and patient communities are aware of the existence of this trial. Naturally, our team is available for consultation should a referring physician believe this could be the appropriate next step for a patient with leukemia or lymphoma," said Roger Giller MD, principal investigator at The Children's Hospital in Denver, Colorado.

Currently, bone marrow transplantation serves as a life-saving treatment for many types of leukemia and lymphoma. According to the National Marrow Donor Program (NMDP) 70% of patients are unable to find a matched donor in their family but are able to turn to international bone marrow transplant registries to search for an unrelated adult donor or cord blood unit. Depending on the patient's race or ethnicity, a well matched, unrelated adult marrow or blood stem cell donor may not be available for as many as 40% of these patients. In that and other circumstances, a stored unrelated cord blood unit can be a valuable alternative option.

Cord blood has fewer matching requirements than bone marrow or peripheral blood transplants, providing the potential to increase the number of suitable transplant matches and to shorten the time it can take to find a match. However, there are a limited number of stem/progenitor cells in each cord blood unit, often limiting unrelated cord blood transplants to younger, smaller pediatric patients. StemEx employs a technology that expands this small number of cord blood stem/progenitor cells, potentially increasing their therapeutic capacity for transplantation in adolescents and adults.

"Our goal is to develop a product that will effectively treat blood cancers like leukemia and lymphoma. It is with this goal in mind that the ExCell team is studying the effects of StemEx. It is our hope that more doctors, patients and the friends and family of patients will become familiar with this study," said David Snyder, vice president of clinical development.