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

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01351545

Run by

Center for International Blood and Marrow Transplant Research

People needed

99999

Starts

2011-10-01

Expected to finish

2041-10-01

Last updated by the study team

2026-07-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University of Florida Shands Medical Center — Gainesville, Florida, United States (enrolling)
• Nemours Children's Hospital - Mayo Jacksonville — Jacksonville, Florida, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Arizona Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• Scripps Green Hospital — La Jolla, California, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• Loma Linda University Cancer Center — Loma Linda, California, United States (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital of Orange County (CHOC) — Orange, California, United States (enrolling)
• Sutter Medical Center — Sacramento, California, United States (enrolling)
• Rady Children's Hospital San Diego — San Diego, California, United States (enrolling)
• Children's Hospital of Los Angeles — Glendale, California, United States (enrolling)
• UCSF (Peds) — San Francisco, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Presbyterian St. Luke's/Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Nemours - Alfred I. duPont Hospital for Children — Brandywine, Delaware, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• University of Miami (peds) — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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