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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
Protocol Number:
J11114
Phase:
NULL
Physician:
Allen Chen
Purpose:
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:
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
Treatment:
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Population:
Both
Last Update
09/01/2014 04:02 AM
 

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