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

RECRUITINGSponsored by Center for International Blood and Marrow Transplant Research
Actively Recruiting
SponsorCenter for International Blood and Marrow Transplant Research
Started2011-10
Est. completion2041-10
Eligibility
Healthy vol.Accepted
Locations142 sites
View on ClinicalTrials.gov →

NCT01351545

Summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Eligibility

Healthy volunteers accepted
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

Conditions18

Acute Lymphoblastic Leukemia (ALL)Acute Myelogenous Leukemia (AML or ANLL)Autoimmune DiseasesCancerChronic Myelogenous Leukemia (CML)Disorders of the Immune SystemHematologic MalignanciesHistiocytic DisordersHodgkin LymphomaInherited Abnormalities of Erythrocyte Differentiation or Function

Locations142 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233
Joseph Chewning, MDjchewning@peds.uab.edu
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Matthew Ulrickson, MD480-256-3223Matthew.Ulrickson@bannerhealth.com
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Dana Salzberg, MD602-546-0920dsalzberg@phoenixchildrens.com
Mayo Clinic Arizona (adults)
Phoenix, Arizona, 85054
James Slack, MDslack.james@mayo.edu
University of Arizona Medical Center - Tucson
Tucson, Arizona, 85224
Emmanuel Katsanis, MDkatsanis@peds.arizona.edu

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