Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
Launched by NEW YORK BLOOD CENTER · Jul 31, 2012
Trial Information
Current as of November 15, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety of a new type of cord blood treatment for patients with certain blood disorders. Cord blood, which comes from the umbilical cord after a baby is born, contains special cells that can help treat diseases affecting the blood and immune system. The researchers want to understand any problems that might happen when these investigational cord blood units are infused into patients.
To be eligible for this study, patients of any age and gender must have a diagnosed condition affecting their blood, either from an inherited disorder, something acquired, or due to previous treatments that damaged their blood cells. However, patients who are currently receiving other licensed or unlicensed cord blood products, especially from outside the U.S., or those needing special processing of the cord blood will not qualify. Participants in the trial can expect close monitoring for any reactions during and after the infusion to ensure their safety. This research aims to gather important information that could help improve treatments in the future.
Gender
ALL
Eligibility criteria
- 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.)
About New York Blood Center
The New York Blood Center (NYBC) is a leading non-profit organization dedicated to advancing the field of transfusion medicine and cellular therapies. With a robust commitment to research and innovation, NYBC conducts clinical trials aimed at improving blood products, enhancing patient outcomes, and promoting public health. Their collaborative approach involves partnerships with academic institutions and healthcare organizations, ensuring rigorous scientific standards and ethical practices in all research endeavors. Through their comprehensive programs, NYBC plays a pivotal role in addressing the critical needs of patients and healthcare providers in the realm of blood donation and transfusion services.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Charleston, South Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Detroit, Michigan, United States
Boston, Massachusetts, United States
Maywood, Illinois, United States
Chicago, Illinois, United States
Zion, Illinois, United States
Rochester, New York, United States
Jackson, Mississippi, United States
Phoenix, Arizona, United States
Cincinnati, Ohio, United States
Duarte, California, United States
Detroit, Michigan, United States
Aurora, Colorado, United States
New York, New York, United States
Madison, Wisconsin, United States
Washington, District Of Columbia, United States
Milwaukee, Wisconsin, United States
Bethesda, Maryland, United States
Columbus, Ohio, United States
Fort Worth, Texas, United States
Milwaukee, Wisconsin, United States
Chicago, Illinois, United States
Los Angeles, California, United States
Tucson, Arizona, United States
Omaha, Nebraska, United States
Atlanta, Georgia, United States
Houston, Texas, United States
San Diego, California, United States
Akron, Ohio, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Tulsa, Oklahoma, United States
Saint Louis, Missouri, United States
Grand Rapids, Michigan, United States
Miami, Florida, United States
Richmond, Virginia, United States
Cleveland, Ohio, United States
Stanford, California, United States
Pittsburgh, Pennsylvania, United States
Aurora, Colorado, United States
Birmingham, Alabama, United States
Los Angeles, California, United States
Denver, Colorado, United States
Wilmington, Delaware, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Saint Petersburg, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Lake Success, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Morgantown, West Virginia, United States
Patients applied
Trial Officials
Patricia Shi, MD
Principal Investigator
NY Blood Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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