Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation
0 Years and older, Male and Female
6637-01 (primary)
NCI-2016-01676
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).
Eligibility
- Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
- Patients: Patients of any age and either gender
- Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Treatment Sites in Georgia
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