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Access and distribution of unlicensed cryopreserved cord blood units

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

Observational Center for International Blood and Marrow Transplant Research · NCT01351545

This study is testing how well unlicensed frozen cord blood units work for helping both kids and adults with blood cancers recover after a transplant.

Quick facts

Study typeObservational
Enrollment99999 (estimated)
SexAll
SponsorCenter for International Blood and Marrow Transplant Research Research network
Locations142 sites (Birmingham, Alabama and 141 other locations)
Trial IDNCT01351545 on ClinicalTrials.gov

What this trial studies

This study focuses on the access and distribution of unlicensed cryopreserved cord blood units (CBUs) for pediatric and adult patients suffering from hematologic malignancies and other related disorders. The primary objective is to evaluate the incidence of neutrophil recovery after cord blood transplantation in a multicenter setting. Secondary objectives include assessing the transmission of infections, serious infusion reactions, overall survival rates, and the incidence of graft versus host disease. The study involves multiple U.S. transplant centers and aims to provide critical data on the use of non-FDA licensed CBUs.

Who should consider this trial

Good fit: Ideal candidates include pediatric and adult patients with inherited or acquired disorders affecting the hematopoietic system.

Not a fit: Patients receiving only licensed cord blood units or those enrolled in other IND protocols will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment options for patients with hematologic malignancies by providing access to unlicensed cord blood units.

How similar studies have performed: Other studies have explored the use of unlicensed cord blood units, but this specific multicenter approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 141 other locations

+92 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematologic MalignanciesInherited Disorders of MetabolismInherited Abnormalities of PlateletsHistiocytic DisordersAcute Myelogenous LeukemiaAcute Lymphoblastic LeukemiaOther Acute LeukemiaChronic Myelogenous Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.