Spots Global Cancer Trial Database for Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
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Trial Identification
Brief Title: Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Official Title: An Open Label Expanded Access Study of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies
Study ID: NCT04260698
Conditions
Interventions
Study Description
Brief Summary: Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.
Detailed Description: Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion. Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood. Omidubicel utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor cells (HPC) expanded in ex vivo cultures. The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
Stanford University Cancer Institute, Palo Alto, California, United States
Loyola University, Cardinal Bernardin Cancer Center, Maywood, Illinois, United States
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
Duke University Medical Center, Durham, North Carolina, United States
Oregon Health & Science University, Portland, Oregon, United States
Contact Details
Name: Mitchell Horwitz, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
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