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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

Clinical Trial Details

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. 

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

Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1205012381

ClinicalTrials.gov:

NCT01656603

Sponsor:

NYBC/NCBP

Status

Open to Enrollment

Sponsor