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European Medicines Agency (EMA) Waives Requirement to Test StemEx(R) in Paediatric Patients 17 Years of Age and Under
Date:1/18/2010

on in adolescents and adults. Gamida Cell's technology takes this small population of cord blood stem cells and cultures it with limited differentiation, to a size that has the potential to offer a therapeutic treatment to larger children and adults. Thus, the goal of the JV is for StemEx to significantly widen the scope of a base treatment, already common practice in children. As such, we believe, and the Agency has agreed, that our first priority in developing StemEx will be to offer the treatment to those patients with the most unmet clinical need, meaning adolescents and adults. This means, we are still on track for a 2011 market launch."

Gamida Cell is currently enrolling for the study of StemEx as an investigational treatment for adolescents (larger children) and adults with leukemia at leading cord blood transplant clinical sites in Italy, Hungary, Spain, Israel and the U.S. For more information about the study: http://www.stemexstudy.com.

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 a
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SOURCE Gamida Cell Ltd.
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