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 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 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).