A Phase I, Multicenter, Dose-Escalation Trial Evaluating Maximum-Tolerated Dose of Single and Repeated Administration of Allogeneic MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia
Graft-vs.-Host Disease (GVHD) is one of the major limitations of allogeneic hematopoietic
stem cell transplants (HSCT). This complication is major cause of morbidity and mortality
and is thought to be initiated by activation of donor T-cells through recognition of
"foreign" cells resident in the transplant recipient. Acute GVHD is associated with damage
to the liver, skin, gastrointestinal tract and mucosa. Moderate to severe GVHD Grades II-IV
occurs in 30-50% of matched related HSCTs and 50-70% of unrelated donor recipients. Severe
GHVD requires intense immunosuppression involving steroids and additional agents to get it
under control, and patients may develop severe infections as a result of such
immunosuppression. An agent or cell therapy that could reduce the incidence and/or severity
of GVHD without increasing relapse or infectious risk in HSCT patients would provide
substantial benefits.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
maximum tolerated dose
30 days
Yes
Richard Maziarz, MD
Principal Investigator
Oregon Health and Science University
United States: Food and Drug Administration
GVHD-2007-001
NCT00677859
July 2008
November 2011
Name | Location |
---|---|
Mayo Clinic Hospital | Phoenix, Arizona 85054-4502 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Texas Transplant Institute | San Antonio, Texas 78229 |
University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
Oregon State University Medical Center | Portland, Oregon 97239 |