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

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT01656603
Trial Phases:	Phase II	Protocol IDs:	6637-01 (primary) NCI-2016-01676
Eligibility:	0 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	New York Blood Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT01656603

Summary

This study will evaluate the safety of infusion of the investigational cord blood units
by carefully documenting all infusion-related problems.

Objectives

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).

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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