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
Study ID: STU 082013-056
This study aims to evaluate the infusion safety of unlicensed, investigational cryopreserved cord blood units (CBus; HPC-CoRD BLooD products) manufactured by the national Cord Blood Program (nCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients.
1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. 2. Patients: Patients of any age and either gender 3. CBU: HPC-CORD BLOOD product manufactured by the NCBP (at least one, if the graft contains more than one units)
The primary aim of this study is to examine the safety of administration of the unlicensed investigational nCBP HPC-CoRD BLooD products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational nCBP CBu.