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Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP 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

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Category
Hematology-Oncology
Oncology
Contact
Farzam Hariri
Location
  • UCLA Westwood
For Providers
NCT No.
NCT01656603
For detailed technical eligibility, visit ClinicalTrials.gov.