A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
Study Status
Open to Enrollment
Study Description
Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. Cord blood units are stored frozen (cryopreserved) in public cord blood banks. Approximately 10,000 cord blood transplants have been performed in children and adults for blood cancers and other blood diseases in the world. Cord blood units that meet all FDA requirements can be licensed.
This study involves transplantation of unlicensed units of cord blood. Therefore these are considered investigational products. The FDA allows these cord blood units to be transplanted in research studies like this one.
The purpose of the study is to evaluate the safety of administering the investigational cord blood units by carefully documenting all infusion-related problems. The cord blood units in this study have been collected, processed, tested and stored by the National Cord Blood Program and meet the criteria for transplantation as approved by the NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).
Participants in this study will receive an unlicensed cord blood transplant. Participants will be asked to remain in the study for 1 year after transplantation.
Disease Status and/or Stage
Hematologic Malignancies and Other Indications Receiving Allogeneic Hematopoieic Stem Cell Transplant
Sponsor
National Cord Blood Program
Key Eligibility
- Males and females of any age
- Receiving an allogeneic hematopoietic stem cell (HSC) transplant using an unlicensed cord blood unit (CBU) at NewYork-Presbyterian/Weill Cornell Medical Center
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- June Greenberg, RN
- (212) 746-2651
- [email protected]
- Bone Marrow Transplant Medical Practice
- (212) 746-2119
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]