Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

Overview

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.

SparkCures ID 358
Trial Phase Phase 2
Enrollment Information Not Available
Treatments
Tags
Trial Sponsors
  • New York Blood Center
NCT Identifier

NCT01656603

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Memorial Sloan Kettering Cancer Center

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Children's of Alabama

Birmingham, AL

Rady Children's Hospital

San Diego, CA

All Children's Hospital

St. Petersburg, FL

Henry Ford Hospital

Detroit, MI

Mayo Clinic (Rochester)

Rochester, MN

Weill Cornell

New York, NY

Methodist Hospital

San Antonio, TX

West Virginia University

Morgantown, WV

Alabama
Children's of Alabama

Birmingham, AL

Arizona
California
Rady Children's Hospital

San Diego, CA

Colorado
Delaware
Florida
All Children's Hospital

St. Petersburg, FL

Georgia
Illinois
Indiana
Kentucky
Maryland
Massachusetts
Michigan
Henry Ford Hospital

Detroit, MI

Minnesota
Mayo Clinic (Rochester)

Rochester, MN

Mississippi
Missouri
Verified Alvin J. Siteman Cancer Center Washington University Medical Campus

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Nebraska
New York
Verified Memorial Sloan Kettering Cancer Center

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Weill Cornell

New York, NY

Ohio
Oklahoma
Pennsylvania
South Carolina
Tennessee
Texas
Methodist Hospital

San Antonio, TX

Virginia
Washington
Washington, D.C.
West Virginia
West Virginia University

Morgantown, WV

Wisconsin
Verified UW Carbone Cancer Center University of Wisconsin Health

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Resources

There are no resources, links or videos to display for this clinical trial.

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