Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Incidence of infusion-related reactions [ Time Frame: within 48 hours of infusion ] [ Designated as safety issue: Yes ]The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. 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 cord blood units.
- engraftment [ Time Frame: six months after transplant ] [ Designated as safety issue: Yes ]This outcome will evaluate engraftment of unlicensed cord blood units
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
Biological: unlicensed CBU
infusion of unlicensed cord blood units
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656603
|Contact: Andromachi Scaradavou, MDfirstname.lastname@example.org|
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|Principal Investigator:||Andromachi Scaradavou, MD||NY Blood Center|