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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

Cancer Type
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Skin Cancer (Non-Melanoma)
Trial Phase
Phase II
Any age, Male and Female
Study Type
Protocol IDs
6637-01 (primary)
Study Sponsor
New York Blood Center


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).

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