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Access to Unlicensed Cord Blood Units for Transplantation

This study is looking at how well unlicensed cryopreserved cord blood units (CBUs) work for children and adults needing transplants for blood cancers (hematologic malignancies) and other conditions. The study will track patients receiving these CBUs to see how quickly their white blood cell count (neutrophil recovery) returns to a healthy level after the transplant. Researchers will measure this at 60 and 100 days after the transplant. You may be able to join if you have a disorder affecting your blood-forming system, whether it's inherited, acquired, or from previous treatment. The study is currently unclear on its recruitment status, but aims to enroll many participants.

Study design
This is an observational study, meaning researchers will watch and collect information from patients receiving these cord blood units. There is no specific phase mentioned, and it plans to enroll up to 99,999 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track neutrophil recovery at 60 and 100 days post-transplant, and overall survival for one year after transplantation.

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NCT01351545

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

Recruiting
Not specifiedAll AgesObservational
Center for International Blood and Marrow Transplant Research
~99,999 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

At a glance

Recruiting sites
113 of 142 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neutrophil recovery of ≥500/mm3 after cord blood transplantation
Measured over Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
+1 more outcome measured

Conditions

Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
Acute Lymphoblastic Leukemia (ALL)
Other Acute Leukemia
Chronic Myelogenous Leukemia (CML)
Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
Other Leukemia
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Multiple Myeloma/ Plasma Cell Disorder (PCD)
Inherited Abnormalities of Erythrocyte Differentiation or Function
Disorders of the Immune System
Autoimmune Diseases
Severe Aplastic Anemia

Explore related trials

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Where it's being run

142 sites across 41 states
California13
Florida12
New York12
Texas11
Illinois8
Ohio7
Michigan6
Pennsylvania6

Study leadership

  • Heather Stefanski, MD, PhD · STUDY_CHAIR · NMDP/CIBMTR

Who to contact

Elizabeth Fosberg, B.A.
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Neutrophil recovery of ≥500/mm3 after cord blood transplantationCord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.

    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.

  • Neutrophil recovery of ≥500/mm3 after cord blood transplantationCord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.

    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.