Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
- Conditions
- Infusion Reactions
- Interventions
- Biological: unlicensed CBU
- Registration Number
- NCT01656603
- Lead Sponsor
- New York Blood Center
- Brief Summary
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 9999
- 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)
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description unlicensed CBU unlicensed CBU The Principal Investigators will be the transplant physicians at participating US transplant centers
- Primary Outcome Measures
Name Time Method Incidence of infusion-related reactions within 48 hours of infusion 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.
- Secondary Outcome Measures
Name Time Method engraftment six months after transplant This outcome will evaluate engraftment of unlicensed cord blood units
Trial Locations
- Locations (71)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Instistute
🇺🇸Boston, Massachusetts, United States
Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital
🇺🇸Columbus, Ohio, United States
University of Miami Health System Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Miami/Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Methodist Hospital / Texas Transplant Institute
🇺🇸San Antonio, Texas, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford Health Care
🇺🇸Stanford, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Cancer Center
🇺🇸Houston, Texas, United States
Penn State Health / Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
UCLA Healthcare
🇺🇸Los Angeles, California, United States
Northside Hosptal
🇺🇸Atlanta, Georgia, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
City of Hope
🇺🇸Duarte, California, United States
Nemour's Children's Clinic and Hospital
🇺🇸Jacksonville, Florida, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Southwestern Regional Medical Center
🇺🇸Tulsa, Oklahoma, United States
Abramson Cancer Center of the University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hopsital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Stephenson Oklahoma Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
St Jude Children's Research Center
🇺🇸Memphis, Tennessee, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
The Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Presbyterian / St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
National Institutes of Health
🇺🇸Bethesda, Maryland, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Doernbecher Children's Hospital / Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
New York Presbyterian Hospital WCMC
🇺🇸New York, New York, United States
Northwell Health - North Shore University Hospital
🇺🇸Lake Success, New York, United States
Florida Hospital, Florida Center for Cellular Therapy
🇺🇸Orlando, Florida, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
West Virginia University Hospitals Inc
🇺🇸Morgantown, West Virginia, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
All Children's Hospital, John Hopkins Medicine
🇺🇸Saint Petersburg, Florida, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Cohen Children's Medical Center of NY
🇺🇸New Hyde Park, New York, United States