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
ID Number 12-1800Principal Investigator(s)
Luis M Isola
Department(s) or Division(s)
Hematology and Medical Oncology
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.
The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. Cord blood units that meet all the FDA safety and processing requirements can be licensed. The Study that you are being asked to participate in involves transplantation of unlicensed units of cord blood. CB units that were collected before these FDA License Requirements were implemented, including most of the CB units currently available in the US CB banks, will not be licensed. These are considered “investigational” products. The FDA allows these cord blood units to be transplanted with patient and physician approval, under certain research studies such as this one.
This study will evaluate the safety of administration of 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 NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).
Your transplant doctor is taking into consideration the possible risks from the unlicensed cord blood units relative to the benefits of their cell dose, HLA match and speed of availability as well as the potential alternative stem cell sources.
Zachary Galitzeck (212) 241-6377
Recruiting Patients: Yes