Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01656603|
Recruitment Status : Recruiting
First Posted : August 3, 2012
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infusion Reactions||Biological: unlicensed CBU||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9999 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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
- Incidence of infusion-related reactions [ Time Frame: within 48 hours of infusion ]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 ]This outcome will evaluate engraftment of unlicensed cord blood units
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656603
|Contact: Andromachi Scaradavou, MDfirstname.lastname@example.org|
Show 60 Study Locations
|Principal Investigator:||Andromachi Scaradavou, MD||NY Blood Center|