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Clinical Trial NCT01861093

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

  • ClinicalTrials.gov ID: NCT01861093
  • Not accepting healthy volunteers
  • UTSW Principal Investigator: VICTOR MICHAEL AQUINO

summary

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.

objective

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.

eligibility

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)

If you are interested in this clinical trial, please contact Sophia Williams on the Children’s Health Research Team.Call 214-648-6554Email