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

View all clinical trial locations sorted by state.

Alabama

Children's of Alabama

Birmingham, AL

Open and Accepting

Arizona

Phoenix Children's Hospital

Phoenix, AZ

Open and Accepting

California

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

Colorado

The Children's Hospital of Colorado

Aurora, CO

Open and Accepting

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Delaware

Alfred I. DuPont Hospital for Children

Wilmington, DE

Open and Accepting

Florida

Nemour's Children's Health (Jacksonville)

Jacksonville, FL

Open and Accepting

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Advent Health Cancer Institute (Orlando)

Orlando, FL

Open and Accepting

All Children's Hospital

St. Petersburg, FL

Open and Accepting

Georgia

Northside Hospital (Atlanta)

Atlanta, GA

Open and Accepting

Children's Healthcare of Atlanta Egleston Hospital

Atlanta, GA

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

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

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Kentucky

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

Louisville, KY

Open and Accepting

Maryland

National Institutes of Health (Bethesda)

Bethesda, MD

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

Henry Ford Hospital

Detroit, MI

Open and Accepting

Helen DeVos Children's Hospital

Grand Rapids, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Mississippi

University of Mississippi Medical Center

Jackson, MS

Open and Accepting

Missouri

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

Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

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

University of Rochester Medical Center Wilmot Cancer Center Strong Memorial Hospital

Rochester, NY

Open and Accepting

Ohio

Akron Children's Hospital

Akron, OH

Open and Accepting

Cincinnati Children's Hospital Medical Center

Cincinnati, OH

Open and Accepting

University Hospitals Seidman Cancer Center Seidman Cancer Center at UH Case Medical

Cleveland, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Oklahoma

OU Health Stephenson Cancer Center

Oklahoma City, OK

Open and Accepting

Cancer Treatment Centers of America Southwestern Regional Medical Center

Tulsa, OK

Open and Accepting

Pennsylvania

Penn State Hershey Medical Center

Hershey, PA

Open and Accepting

Children's Hospital of Philadelphia

Philadelphia, PA

Open and Accepting

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

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

Tennessee

St. Jude Children's Research Center

Memphis, TN

Open and Accepting

Texas

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

Virginia

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

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

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

Wisconsin

University of Wisconsin - Carbone Cancer Center University of Wisconsin Health

Madison, WI

Open and Accepting

Children's Hospital of Wisconsin

Milwaukee, WI

Open and Accepting
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