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(Adult/Pediatric) 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
|Bone Marrow Transplant (BMT)
- Primary Objective
- The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm³ after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
- Secondary Objectives (In patients receiving a non-licensed CBU):
- Assess incidence of graft rejection
- Assess incidence of transmission of infection
- Assess incidence of serious infusion reaction
- Determine 1 year survival after cord blood transplantation
- Assess cumulative incidence of acute GVHD grades II to IV and grades III to IV
- Assess cumulative incidence of chronic GVHD
- Determine platelet engraftment of >20,000 mcL and >50,000 mcL
- Determine CBU-derived engraftment
- Patients with FDA-specified indications (see Appendix B for further details):
- Hematological malignancies
- Certain lysosomal storage and peroxisomal enzyme deficiency disorders
- Hurler syndrome (MPS I)
- Krabbe Disease (Globoid Leukodystrophy)
- X-linked Adrenoleukodystrophy
- Primary immunodeficiency diseases
- Bone marrow failure
- Signed informed consent (and signed assent, if applicable)
- Pediatric and adult patients of any age
- Patients who are receiving only licensed CBUs
- Cord blood transplant recipients at international transplant centers
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