A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
- Sponsor:
- National Cord Blood Program
- Sponsor Study ID:
- 6637-01; 13-H-0116
- CTO #:
- 101774
- NCT Number:
- NCT01656603
- Phase:
- II
- Protocol Type:
- Treatment
- Age Group:
- Adults
- Disease Sites:
- Hodgkin's Lymphoma; Lymphoid Leukemia; Multiple Myeloma; Myeloid and Monocytic Leukemia; Non-Hodgkin's Lymphoma; Other Hematopoietic
- Study Objectives:
- The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP HPC-CORD BLOOD products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.
- eConsent:
- Not available
- Study Documents:
-
Open Study Documents
(MUSC NetID required for document access)
For more information about this trial please contact the study team:
-
Medical University of South Carolina
- Principal Investigator, Hudspeth, Michelle, at hudspeth@musc.edu , or please call +1 843-792-0381.
- Study Coordinator, Mendiola, Hannah, at mendiola@musc.edu .
Trial opened at the following institutions:
Medical University of South Carolina