The purpose of this study is to determine if MultiStem® can safely be given to patients with acute leukemia, chronic myeloid leukemia, or myelodysplasia after they have received hematopoietic stem cell transplantation.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Patients will receive a single IV infusion of MultiStem® 2 days after HSCT.
Patients will receive either 3 weekly IV infusions or 5 weekly infusions of MultiStem®
Mayo Clinic Hospital
Phoenix, Arizona, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Oregon State University Medical Center
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
maximum tolerated dose
Time frame: 30 days
incidence of grade III/IV GVHD
Time frame: 100 days
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Texas Transplant Institute
San Antonio, Texas, United States
UZ Leuven
Leuven, Belgium