Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Single intravenous injection/infusion
Children's Hospital of Orange County
Orange, California, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
University of Minnesota: Masonic Cancer Center, BMT Clinic, and Fairview Medical Center
Minneapolis, Minnesota, United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Safety and tolerability
Time frame: 100 days post transplant
Neutrophil and platelet recovery
Time frame: 100 days post transplant
Persistence of CLT-008 derived cells
Time frame: 100 days post transplant
Graft-versus-host disease (GVHD)
Time frame: 100 days post transplant
Non-relapse mortality
Time frame: 100 days post transplant
Infections
Time frame: 42 days post transplant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.