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Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

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

Who can join

All ages · All sexes

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 gender
3. 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 centers
4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

About the study

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

What is being tested

• unlicensed CBU (biological)

Sponsor: New York Blood Center · Participants: 9,999 · Started: 2012-02

Contact the study team

• Dorothy Sung · Phone: 718-706-5202
• National Cord Blood Program, New York Blood Center (General) · Phone: 917-710-9143

Official record on ClinicalTrials.gov — NCT01656603

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.