Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the National Cord Blood Program (NCBP) for Unrelated Transplantation INVESTIGATIONAL CORD BLOOD UNITS

What's the purpose of this trial?

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

This trial is currently open and accepting patients.

What will happen during the trial?

The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.

Definitions of Infusion-related adverse reactions:

Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.

Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
  2. Patients: Patients of any age and either gender
  3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Exclusion Criteria:

  1. Patients who are receiving licensed cord blood products (only)
  2. Patients who are receiving unlicensed cord blood products from other banks (only)
  3. Patients who are transplanted at non-US transplant centers
  4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Additional Trial Information

Phase 2

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Trial Locations

All Trial Locations

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Children's of Alabama

Birmingham, AL

Open and Accepting


Phoenix Children's Hospital

Phoenix, AZ

Open and Accepting


City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Open and Accepting

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Open and Accepting

Rady Children's Hospital

San Diego, CA

Open and Accepting

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting


The Children's Hospital of Colorado

Aurora, CO

Open and Accepting

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting


Alfred I. DuPont Hospital for Children

Wilmington, DE

Open and Accepting


Nemour's Children's Health (Jacksonville)

Jacksonville, FL

Open and Accepting

Advent Health Cancer Institute (Orlando)

Orlando, FL

Open and Accepting

All Children's Hospital

St. Petersburg, FL

Open and Accepting


Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Children's Healthcare of Atlanta Egleston Hospital

Atlanta, GA

Open and Accepting


Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, IL

Open and Accepting

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Open and Accepting


Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting


U of L - Brown Cancer Center University of Louisville Jewish Hospital

Louisville, KY

Open and Accepting


National Institutes of Health (Bethesda)

Bethesda, MD

Open and Accepting


Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting


Henry Ford Hospital

Detroit, MI

Open and Accepting

Helen DeVos Children's Hospital

Grand Rapids, MI

Open and Accepting


Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting


University of Mississippi Medical Center

Jackson, MS

Open and Accepting


Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

SSM Health Saint Louis University Hospital

St. Louis, MO

Open and Accepting


New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Weill Cornell

New York, NY

Open and Accepting

Steven and Alexandra Cohen Children's Medical Center Northwell Health

Queens, NY

Open and Accepting


Akron Children's Hospital

Akron, OH

Open and Accepting

Cincinnati Children's Hospital Medical Center

Cincinnati, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting


OU Health Stephenson Cancer Center

Oklahoma City, OK

Open and Accepting


Penn State Hershey Medical Center

Hershey, PA

Open and Accepting

Children's Hospital of Philadelphia

Philadelphia, PA

Open and Accepting

UPMC Children's Hospital of Pittsburgh

Pittsburgh, PA

Open and Accepting

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Open and Accepting


St. Jude Children's Research Center

Memphis, TN

Open and Accepting


Children's Medical Center of Dallas

Dallas, TX

Open and Accepting

Cook Children's Medical Center

Fort Worth, TX

Open and Accepting

Texas Children's Cancer Center

Houston, TX

Open and Accepting


UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Open and Accepting


Washington, D.C.

Children's National Medical Center

Washington, DC

Open and Accepting

West Virginia

WVU Cancer Institute Mary Babb Randolph Cancer Center

Morgantown, WV

Open and Accepting


Children's Hospital of Wisconsin

Milwaukee, WI

Open and Accepting
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