Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
Trial ID or NCT#
NCT01861093
Status
RECRUITING
Purpose
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 4 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 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 gender3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Exclusion Criteria:
- 1. Patients who are receiving licensed cord blood products (only)2. Patients who are receiving unlicensed cord blood products from other banks (only)3. Patients who are transplanted at non-US transplant centers4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Contact us to find out if this trial is right for you.
Contact
Khanh Nguyen
650-736-2558
View on ClinicalTrials.gov
