Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

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.

Primary Objective:

The primary objective of this study 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 Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

  • Assess incidence of transmission of infection
  • Assess incidence of serious infusion reaction
  • Determine 1 year overall survival after cord blood transplantation
  • Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  • Assess cumulative incidence of chronic GVHD
  • Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Clinical Study Identifier: NCT01351545

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University of Utah

Salt Lake City, UT United States
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University of Massachusetts

Worcester, MA United States
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University of Chicago

Chicago, IL United States
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Phoenix Children's Hospital

Phoenix, AZ United States
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Tulane Medical Center

New Orleans, LA United States
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Vanderbilt University

Nashville, TN United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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Medical College of Wisconsin

Milwaukee, WI United States
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University of Michigan

Ann Arbor, MI United States
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Tufts Medical Center

Boston, MA United States
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Scripps Green Hospital

La Jolla, CA United States
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Roger Williams Medical Center

Providence, RI United States
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Western Penn Hospital

Pittsburgh, PA United States
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UC Davis Cancer Center

Sacramento, CA United States
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University of Iowa

Iowa City, IA United States
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Avera Transplant Institute

Sioux Falls, SD United States
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Cleveland Clinic

Cleveland, OH United States
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VA Puget Sound HCS

Seattle, WA United States
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Nih/Nhlbi

Bethesda, MD United States
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Johns Hopkins

Baltimore, MD United States
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Medical College of Georgia

Augusta, GA United States
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University of Kansas

Westwood, KS United States
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All Children's Hospital

Saint Petersburg, FL United States
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UCLA

Los Angeles, CA United States
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Yale New Haven Hospital

New Haven, CT United States
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M.D. Anderson Cancer Center

Houston, TX United States
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Sutter Medical Center

Sacramento, CA United States
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Emory University Hospital

Atlanta, GA United States
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Beth Israel Deaconess

Boston, MA United States
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Washington University St. Louis

Saint Louis, MO United States
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City of Hope

Duarte, CA United States
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Mayo Clinic - Jacksonville

Jacksonville, FL United States
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Nih/Niaid

Bethesda, MD United States
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Cook Children's Hospital

Fort Worth, TX United States
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Cincinnati Children's Hospital

Cincinnati, OH United States
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West Virginia University

Morgantown, WV United States
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Medical City Dallas

Dallas, TX United States
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University of Virginia

Charlottesville, VA United States
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The Jewish Hospital

Cincinnati, OH United States
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Karmanos Cancer Institute

Detroit, MI United States
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Northside Hospital

Atlanta, GA United States
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UCSF (adults)

San Francisco, CA United States
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Stony Brook University Hospital

Stony Brook, NY United States
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Mayo Clinic Rochester

Rochester, MN United States
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Mount Sinai Medical Center

New York, NY United States
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Helen DeVos Children's Hospital

Grand Rapids, MI United States
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Henry Ford Health System

Detroit, MI United States
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Levine Children's Hospital

Charlotte, NC United States
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UCSF (peds)

San Francisco, CA United States
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University of Kentucky

Lexington, KY United States
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NIH/NCI

Bethesda, MD United States
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Spectrum Health

Grand Rapids, MI United States
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North Shore University Hospital

Lake Success, NY United States
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Westchester Medical Center

New York, NY United States
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Wake Forest University

Winston-Salem, NC United States
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Recruitment Status: Open


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