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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
Johns Hopkins Kimmel Cancer Center in Baltimore
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
Genders Eligible for Study: Both Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers. Criteria 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 Exclusion Criteria: Patients who are receiving only licensed CBUs Cord blood transplant recipients at international transplant centers
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
05/23/2017 05:03 AM