Clinical Trial Details
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Phase IIInterventional
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Protocol: IRB00067778NCT: NCT01656603
Overview
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Eligibility
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Child, Adult, Older Adult |
Inclusion Criteria:
- Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
- Patients: Patients of any age and either gender
- Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Exclusion Criteria:
- Patients who are receiving licensed cord blood products (only)
- Patients who are receiving unlicensed cord blood products from other banks (only)
- Patients who are transplanted at non-US transplant centers
- Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)