Safety Study of Cord Blood Units for Stem Cell Transplants
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|ClinicalTrials.gov Identifier: NCT01861093|
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : January 18, 2020
- Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants have been performed in children and adults for blood cancers and other diseases in the world. These transplants have helped save lives and improve treatments. However, not all available units of cord blood have been collected, stored, and licensed according to specific government requirements. These unlicensed units can still be used in transplant, but they can only be given as part of specific research studies. This study will evaluate the safety of giving these unlicensed units by recording any problems that may occur during and after giving the cord blood.
- To test the safety and effectiveness of unlicensed cord blood units in people who need stem cell transplants.
- Individuals who are scheduled to have a stem cell transplant.
- Participants will be screened with a medical history and physical exam.
- Participants will receive the cord blood unit as part of their stem cell transplant procedure. The transplant will be performed according to the current standard of care for the procedure.
- After the transplant, participants will be monitored for up to 1 year. Any problems or side effects from the transplant will be treated as necessary. All outcomes will be reported to the National Cord Blood Program and to the Center for International Blood and Marrow Transplant.
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia Leukemia Myelodysplastic Syndrome (MDS) Lymphoma||Biological: Cord Blood Units||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 16, 2015|
|Estimated Primary Completion Date :||November 30, 2037|
|Estimated Study Completion Date :||November 30, 2037|
At least one
Biological: Cord Blood Units
cord blood units for transplants
- safety of administration of the unlicensed investigational NCBP HPC-CORD BLOOD products [ Time Frame: 1 year post transplant ]safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861093
|Contact: Jennifer S Wilder, R.N.||(301) firstname.lastname@example.org|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Richard W Childs, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|