ExCell Information for Patients
What is the ExCell study?
ExCell is a clinical trial studying StemEx® as an alternative transplantation option for adolescents and adults with leukemia, lymphoma and other high risk hematological malignancies, who are unable to find a matched, related bone marrow donor.
The ExCell study is sponsored by the Gamida Cell-Teva Joint Venture. The JV is committed to advancing the clinical development of StemEx® and improving the treatment of adolescents and adults with hematological malignancies.
Why is this study being conducted?
Umbilical cord blood has lower matching requirements for transplantation than bone marrow or peripheral blood grafts and is therefore considered a possible alternative source for grafting.
In addition, cord blood transplants have been associated with a reduced risk for Graft versus Host Disease (GvHD).
Umbilical cord blood contains a limited number of stem/progenitor cells (the "building blocks" of a new blood system) and has therefore historically been used primarily for transplants in small children, who require fewer numbers of these cells. We have developed a technology that expands the number of stem/progenitor cells, so that there are enough cells to perform a cord blood transplant in adolescents and adults as well.
The purpose of the ExCell study is to determine the safety and the therapeutic effects of transplanting StemEx® in patients with hematological malignancies including leukemia and lymphoma.
What is StemEx® ?
StemEx® is a graft of stem/progenitor cells isolated and expanded from a portion of a single unit of umbilical cord blood and transplanted in combination with non-expanded cells from the same unit.
Who will take part in this study?
The ExCell study will enroll 100 participants, ages 12 to 55, with leukemia or lymphoma, who do not have a matched, family-related bone marrow donor and who meet all of the eligibility criteria of the study. All of the enrolled patients will be receiving StemEx®.
Where is the study taking place?
The study will take place at leading cord blood transplantation centers; 15 in the United States and 11 in Europe and Israel:
US sites (in alphabetical order by state)
Los Angeles, California
Orange, California
Aurora, Colorado
Denver, Colorado
Chicago, Illinois
Maywood, Illinois
Hackensack, New Jersey
New York, New York – 2 sites
Durham, North Carolina
Cleveland, Ohio
Pittsburgh, Pennsylvania – 2 sites
Houston, Texas
San Antonio, Texas
Europe and Israel sites (in alphabetical order by country)
Paris, France
Budapest, Hungary
Tel Hashomer, Israel
Haifa, Israel
Rome, Italy
Florence, Italy
Badalona, Spain
Barcelona, Spain – 2 sites
Valencia, Spain – 2 sites
Click here for a list of Study Sites & Investigators
How can patients be referred to the ExCell Study?
Click here for a list of Study sites and Investigators