A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

About

Brief Summary

This study is for subjects who are going to receive a cord blood transplant and the doctor has determined that the best choice of a cord blood unit is one that may not meet all the new FDA (Food and Drug administration) standards but does meet the standards set by the National Marrow Donor Program (NMDP). The primary purpose of this study is to provide access to such cord blood units and to see how quickly the recipients counts return to normal after the transplant.

Study Type

Observational

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

N/A

Maximum Age

N/A

This study is for pediatric and adult patients of any age.

For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion Criteria:

Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
Pediatric and adult patients of any age

Exclusion Criteria:

Patients who are receiving only licensed CBUs
Cord blood transplant recipients at international transplant centers
Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

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