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  • Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

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

Principal Investigator

Lazaros Lekakis

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20140042
National Clinical Trials Identifier NCT01656603

Clinical Trial Summary

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


Phase

Phase 2


Funding Agency/Sponsor

Externally Peer-Reviewed


Disease

Leukemia/heme


Enrollment Eligibility

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.)


Contact Information

Phone Number 305-243-2647
Get detailed information on ClinicalTrials.Gov

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