This study is currently recruiting participants.
Number
12-H-0064
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: 75 Years
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
Transplant; Umbilical Cord Blood; Graft Rejection; Graft Versus Host Disease
Recruitment Keyword(s)
Condition(s)
Myelodysplastic Syndrome (MDS); Hematologic Neoplasms; Hematologic Diseases; Severe Aplastic Anemia
Investigational Drug(s)
Cryopreserved Cord Blood Units (CBU)
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Cord Blood Transplant
Supporting Site
National Heart, Lung and Blood Institute
- 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.
Objectives:
- To allow selected cord blood units that do not meet current FDA standards to be used for transplant.
Eligibility:
- Individuals who need cord blood units for transplant, and who best match cord blood units that are not FDA-licensed.
Design:
- 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.
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INCLUSION CRITERIA: -Patients of 4-75 years of age with FDA-specified indications -Signed informed consent (and assent when applicable) obtained prior to study enrollment EXCLUSION CRITERIA: -Patients who are receiving only licensed CBUs -Cord blood transplant recipients at international transplant centers -Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) -Patients whose selected unlicensed CBU(s) will be more than minimally manipulated Design -Treatment description, including pre-transplant conditioning and GVHD prophylaxis, will occur per each transplant center s specification.
-Patients of 4-75 years of age with FDA-specified indications
-Signed informed consent (and assent when applicable) obtained prior to study enrollment
EXCLUSION CRITERIA:
-Patients who are receiving only licensed CBUs
-Cord blood transplant recipients at international transplant centers
-Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
-Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
Design
-Treatment description, including pre-transplant conditioning and GVHD prophylaxis, will occur per
each transplant center s specification.
Principal Investigator
Referral Contact
For more information: