Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

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).