Protocol Details
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
This study is currently recruiting participants.
Summary
Number |
13-H-0116 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Years
Max Age: 99 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
None |
Keywords |
Unrelated Hematopoietic Stem Cell Transplantation;
Cryopreserved Cord Blood Units;
National Cord Blood Program |
Recruitment Keyword(s) |
None |
Condition(s) |
Aplastic Anemia;
Leukemia;
Myelodysplastic Syndrome (MDS);
Lymphoma |
Investigational Drug(s) |
Unlicensed Investigational NCBP HPC-CORD Blood Products
|
Investigational Device(s) |
None |
Intervention(s) |
Biological/Vaccine: Cord Blood Units
|
Supporting Site |
National Cancer InstituteNational Heart, Lung and Blood InstituteNational Institute of Allergy and Infectious DiseasesNational Cord Blood Program, New York Blood CenterNational Heart, Lung, and Blood Institute |
Background:
- 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.
Objectives:
- To test the safety and effectiveness of unlicensed cord blood units in people who need stem cell transplants.
Eligibility:
- Individuals who are scheduled to have a stem cell transplant.
Design:
- 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.
Eligibility
INCLUSION CRITERIA:
-Patients of any age or either gender with indications for receipt of investigational HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for unrelated hematopoietic stem cell transplantation.
-Signed informed consent (and assent when applicable).
EXCLUSION CRITERIA:
-Patients who are receiving licensed CB products (only)
-Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT01656603