Open Actively Recruiting

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

About

Brief Summary

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

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Gender

All

Healthy Volunteers

Minimum Age

N/A

Maximum Age

N/A

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)

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.)

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Study Stats

Protocol No.

15-001812