A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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
Center for International Blood and Marrow Transplant Research
99,999 participants
Oct 1, 2011
OBSERVATIONAL
Conditions
Summary
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
Eligibility
Inclusion Criteria3
- Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
- Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
- Pediatric and adult patients of any age
Exclusion Criteria4
- 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
Interventions
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
Locations(142)
View Full Details on ClinicalTrials.gov
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NCT01351545