A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.
Definitions of Infusion-related adverse reactions:
Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.
Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Inclusion Criteria:
Exclusion Criteria:
dsung@nybc.org718-706-5202
ncbp@nybc.org917-710-9143
Birmingham, Alabama 35233, United States
Washington D.C., District of Columbia 20010, United States
Miami, Florida 33136, United States
Orlando, Florida 32804, United States
St. Petersburg, Florida 33701, United States
Chicago, Illinois 60611, United States
St Louis, Missouri 63110, United States
Lake Success, New York 10042, United States
Portland, Oregon 97239, United States
Hershey, Pennsylvania 17033, United States
Philadelphia, Pennsylvania 19104, United States
Richmond, Virginia 23298, United States
Seattle, Washington 98109, United States