Transplants With Unlicensed Preserved Cord Blood
- Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under certain safety standards. However, most available cord blood units were collected before the FDA set these standards. These units may not meet FDA standards, but they do meet similar standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that do not meet the new FDA standards may be used for transplants only as part of a research study. Doctors want to allow people who need transplants to receive cord blood that meets NMDP standards but may not meet FDA standards.
- To allow selected cord blood units that do not meet current FDA standards to be used for transplant.
- Individuals who need cord blood units for transplant, and who best match cord blood units that are not FDA-licensed.
- Participants will provide consent to receive cord blood that meets NMDP standards but may not meet FDA standards.
- Participants will remain on the study for observation for up to 1 year after transplant, or until they withdraw from the study for personal or medical reasons.
|Myelodysplastic Syndrome (MDS) Hematologic Neoplasms Hematologic Diseases Severe Aplastic Anemia||Procedure: Cord Blood Transplant||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications|
- To examine the incidence of neutrophil recovery of greater than or equal to 500/mm (3) after unlicensed CBU transplant.
- Assess incidence of graft rejection, transmission of infection, serious infusion reactions.
- Determine 1 year survival.
- Assess cumulative incidence of acute GVHD (grades II to IV), (grades III to IV), and incidence of chronic GVHD.
|Study Start Date:||February 1, 2012|
|Estimated Study Completion Date:||October 20, 2036|
|Estimated Primary Completion Date:||October 20, 2036 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553461
|Contact: Richard W Childs, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Richard W Childs, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|