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Complete title: 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
|Research Study Number||2531.00|
|Principal Investigator||Ann Woolfrey, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.
- Patients with FDA-specified indications: Hematological malignancies, Certain lysosomal storage and peroxisomal enzyme deficiency disorders (Hurler syndrome (MPS I), Krabbe Disease (Globoid Leukodystrophy),and X-linked Adrenoleukodystrophy), Primary immunodeficiency diseases, Bone marrow failure, and Beta-thalassemia
- Signed informed consent (and signed assent, if applicable)
- Pediatric and adult patients of any age
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Cord blood transplant recipients at international transplant centers
Other exclusion criteria may apply.
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