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A Multi-center Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adults Patients with Hematologic Malignancies and Other Indications

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.

The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. Cord blood units that meet all the FDA requirements can be licensed. The Study that you are being asked to participate in involves transplantation of unlicensed units of cord blood. 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.

Key Eligibility: 
  • Open to men and women above the age of 18
  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent obtained prior to study enrollment

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 #:

1108011902

ClinicalTrials.gov:

NCT01351545

Sponsor:

10-CBA

Status

Open to Enrollment

Age Group

Adult

Sponsor