Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
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
1 other identifier
interventional
9,999
1 country
71
Brief Summary
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Longer than P75 for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 31, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 13, 2026
April 1, 2026
18.8 years
July 31, 2012
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of infusion-related reactions
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.
within 48 hours of infusion
Secondary Outcomes (1)
engraftment
six months after transplant
Study Arms (1)
unlicensed CBU
EXPERIMENTALThe Principal Investigators will be the transplant physicians at participating US transplant centers
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
- Patients: Patients of any age and either gender
- Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
You may not qualify if:
- Patients who are receiving licensed cord blood products (only)
- Patients who are receiving unlicensed cord blood products from other banks (only)
- Patients who are transplanted at non-US transplant centers
- Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
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 D.C., 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
St. 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
St Louis, Missouri, 63110, United States
St. Louis University Hospital
St 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
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Gehrie, MD
New York Blood Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2012
First Posted
August 3, 2012
Study Start
February 1, 2012
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share