Open Actively Recruiting

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. \n\n

Study Type
Observational
Phase
Phase II

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. \n\n  \n\nFor 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

Join this Trial

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Study Stats
Protocol No.
11-003111
Category
Hematology-Oncology
Oncology
Contact
Farzam Hariri
Location
  • UCLA Westwood
For Providers
NCT No.
NCT01351545
For detailed technical eligibility, visit ClinicalTrials.gov.