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A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients


N/A
N/A
N/A
Open (Enrolling)
Both
Infusion Reactions

Thank you

Trial Information

A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients


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.)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of infusion-related reactions of the unlicensed, investigational cord blood units

Outcome Description:

The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. 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 cord blood units.

Outcome Time Frame:

within 48 hours of infusion

Safety Issue:

Yes

Principal Investigator

Andromachi Scaradavou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NY Blood Center

Authority:

United States: Food and Drug Administration

Study ID:

6637-01

NCT ID:

NCT01656603

Start Date:

February 2012

Completion Date:

December 2020

Related Keywords:

  • Infusion Reactions
  • cord blood
  • transplantation
  • stem cells
  • adverse event

Name

Location
Cedars Sinai Medical Center Los Angeles, California  90048-1804
Cleveland Clinic Foundation Cleveland, Ohio  44195
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Medical University of South Carolina Charleston, South Carolina  29425-0721
All Children's Hospital St. Petersburg, Florida  33701
Texas Children's Cancer Center Houston, Texas  77030-2399
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Abramson Cancer Center of the University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104-4283
University of Virginia Charlottesville, Virginia  22908
University of Colorado Hospital Denver, Colorado  80262
UCSD Moores Cancer Center La Jolla, California  93093
Rady Children's Hospital San Diego, California  92123
Helen DeVos Children's Hospital Grand Rapids, Michigan  49503
The Children's Hospital of Colorado Aurora, Colorado  80045
Dana Farber Cancer Instistute Boston, Massachusetts  02215
University of Arizona Medical Center Tucson, Arizona  85724
Nemour's Children's Clinic and Hospital Jacksonville, Florida  32207
Florida Hospital, Florida Center for Cellular Therapy Orlando, Florida  32804
Northside Hosptal Atlanta, Georgia  30242
New York Presbyterian Hospital WCMC New York, New York  10021
Stephenson Oklahoma Cancer Center Oklahoma City, Oklahoma  73104
Children's Hopsital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15224
St Jude Children's Research Center Memphis, Tennessee  38105
University of Wisconsin Hopsital and Clinics Madison, Wisconsin  53792