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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
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 | ||
| Phase | NA |
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Study Population
Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.
Inclusion Criteria:
- 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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Keywords
Hematologic Malignancies
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