A multicenter safety study of unlicensed investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
S
Sherif Farag, MD
Primary Investigator
Recruiting
100 years and younger
All
Phase
N/A
3 Locations
Brief description of study
The purpose of this study is to evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.
Detailed description of study
The purpose of this study is to evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Blood Transfusion, Riley
-
Age: - 100 Years
-
Gender: All
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
Pediatric and adult patients of any age
Exclusion Criteria
Patients who are receiving only licensed CBUs
Cord blood transplant recipients at international transplant centers
Additional Information: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
Pediatric and adult patients of any age
Exclusion Criteria
Patients who are receiving only licensed CBUs
Cord blood transplant recipients at international transplant centers
Participants will not be paid for their participation.
Updated on
14 Sep 2024.
Study ID: 1207009172, NCT01656603, 6637-01
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