RECRUITING

Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

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Conditions

Infusion Reactionscord bloodtransplantationstem cellsadverse event

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2012-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01656603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
  2. 2. Patients: Patients of any age and either gender
  3. 3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
  1. 1. Patients who are receiving licensed cord blood products (only)
  2. 2. Patients who are receiving unlicensed cord blood products from other banks (only)
  3. 3. Patients who are transplanted at non-US transplant centers
  4. 4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

Contacts and Locations

Study Contact

Dorothy Sung
CONTACT
718-706-5202
dsung@nybc.org
Emeline Masson Frenet
CONTACT
718-752-4710
ncbp@nybc.org

Principal Investigator

Patricia Shi, MD
PRINCIPAL_INVESTIGATOR
NY Blood Center

Study Locations (Sites)

Children's of Alabama
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
University of Arizona Medical Center
Tucson, Arizona, 85724
United States
City of Hope
Duarte, California, 91010
United States
UCSD Moores Cancer Center
La Jolla, California, 92093
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA Healthcare
Los Angeles, California, 90095
United States
Rady Children's Hospital
San Diego, California, 92123
United States
Stanford Health Care
Stanford, California, 94305
United States
The Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Presbyterian / St. Luke's Medical Center
Denver, Colorado, 80218
United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19901
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Nemour's Children's Clinic and Hospital
Jacksonville, Florida, 32207
United States
University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University of Miami/Jackson Memorial Hospital
Miami, Florida, 33136
United States
Florida Hospital, Florida Center for Cellular Therapy
Orlando, Florida, 32804
United States
All Children's Hospital, John Hopkins Medicine
Saint Petersburg, Florida, 33701
United States
Northside Hosptal
Atlanta, Georgia, 30242
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Midwestern Regional Medical Center
Zion, Illinois, 60099
United States
Indiana University
Indianapolis, Indiana, 46204
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40102
United States
National Institutes of Health
Bethesda, Maryland, 20892
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Instistute
Boston, Massachusetts, 02215
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center
Saint Louis, Missouri, 63110
United States
St. Louis University Hospital
Saint Louis, Missouri, 63110
United States
The Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Northwell Health - North Shore University Hospital
Lake Success, New York, 10042
United States
Cohen Children's Medical Center of NY
New Hyde Park, New York, 11042
United States
New York Presbyterian Hospital WCMC
New York, New York, 10021
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10067
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Akron Children's Hospital
Akron, Ohio, 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Seidman Cancer Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Arthur G. James Cancer Hospital
Columbus, Ohio, 43210
United States
Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
United States
Doernbecher Children's Hospital / Oregon Health & Science University
Portland, Oregon, 97239
United States
Penn State Health / Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Abramson Cancer Center of the University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hopsital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
St Jude Children's Research Center
Memphis, Tennessee, 38105
United States
Children's Medical Center of Dallas
Dallas, Texas, 75390-9063
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Texas Children's Cancer Center
Houston, Texas, 77030
United States
Methodist Hospital / Texas Transplant Institute
San Antonio, Texas, 78229
United States
University of Virginia
Charlottesville, Virginia, 22905
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States
Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
West Virginia University Hospitals Inc
Morgantown, West Virginia, 26506
United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: New York Blood Center

  • Patricia Shi, MD, PRINCIPAL_INVESTIGATOR, NY Blood Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2012-02
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • cord blood
  • transplantation
  • stem cells
  • adverse event

Additional Relevant MeSH Terms

  • Infusion Reactions