Participating clinical sites include, in alphabetical order:
• Hospital Clínic of Barcelona, Barcelona
Principal Investigator, Dr. Enric Carreras, MD
• Hospital Clínico Universitario de Valencia, Valencia
Principal Investigator, Dr. Cristina Arbona, MD
• Hospital de la Santa Creu i Sant Pau, Barcelona
Principal Investigator, Dr. Jorge Sierra, MD
• Hospital Germans Trias i Pujol, Barcelona
Principal Investigator, Dr. Christelle Ferra, MD
• Hospital Universitario La Fe, Valencia
Principal Investigator, Dr. Guillermo Sanz, MD
The trial is assessing the safety and efficacy of StemEx as a treatment for hematological malignancies, including leukemia and lymphoma, in a single arm, global, pivotal marketing authorization trial. StemEx is a graft of expanded stem/progenitor cells, derived from a single unit of umbilical cord blood and 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 a study that gives clinicians the opportunity to explore a new path in the pursuit of a therapeutic treatment for patients with blood cancers. Cord blood can successfully be used to treat leukemia and lymphoma in young children. It stands to reason therefore that the same basic source could also be used to effectively treat adolescents and adults. The ExCell trial provides an opportunity to determine if StemEx can indeed make this a possibility.
Cord blood has less 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 cord blood, enabling a quantity sufficient generally only for pediatric treatment. StemEx® employs a technology that expands this small number of cord blood stem/progenitor cells, increasing their therapeutic capacity for transplantation in adolescents and adults.
It is estimated that more than 11,000 patients in the European Union are in need of an allogeneic (from a source outside of the patient’s body) hematopoietic (blood) stem cell transplantation. This is an unofficial figure calculated based on the method proposed by the US government's General Accounting Office (GAO) report and The EBMT Activity Survey 2006 on Hematopoietic Stem Cell Transplantation: Focus on the Use of Cord Blood Products.
“We are enthusiastic about working with these five outstanding hospitals in Spain, the esteemed principal investigators and their experienced staves. Together, we hope to demonstrate the advantage of the StemEx transplant for patients,” said Dr. David Snyder, vice president of clinical development at Gamida Cell.
About Gamida Cell
Gamida Cell Ltd. is a world leader in stem cell expansion technologies and therapeutic products. The company is developing a pipeline of products in stem cell transplantation and in tissue regeneration to effectively treat debilitating and often fatal illnesses such as cancer, hematological, autoimmune and ischemic diseases. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood and bone marrow, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s flagship product, StemEx, is now being studied as a therapy for patients with blood cancers in an international pivotal trial at leading transplant centers in the U.S., Europe and Israel. StemEx has orphan drug designation in the U.S. and in Europe. Gamida Cell’s current shareholders include: Elbit Imaging, Biomedical Investment, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: www.gamida-cell.com. For information regarding the ExCell study: www.stemexstudy.com.