We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

This study is currently recruiting participants.
Verified April 2017 by New York Blood Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656603
First Posted: August 3, 2012
Last Update Posted: April 21, 2017
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.
Information provided by (Responsible Party):
New York Blood Center
July 31, 2012
August 3, 2012
April 21, 2017
February 2012
December 2019   (Final data collection date for primary outcome measure)
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.
Incidence of infusion-related reactions of the unlicensed, investigational cord blood units [ 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.
Complete list of historical versions of study NCT01656603 on ClinicalTrials.gov Archive Site
engraftment [ Time Frame: six months after transplant ]
This outcome will evaluate engraftment of unlicensed cord blood units
Incidence of transmission of infections after unrelated transplantation with investigational cord blood units [ Time Frame: six months after transplant ]
This outcome will evaluate recipient bacteremia related to contaminated cord blood product or recipient seroconversion to or infection with any of the FDA listed relevant communicable diseases within 6 months from the investigational cord blood infusion, which is determined to be caused by the product.
Not Provided
Not Provided
 
Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
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
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).

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infusion Reactions
Biological: unlicensed CBU
infusion of unlicensed cord blood units
Experimental: unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
Intervention: Biological: unlicensed CBU
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9999
December 2020
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
  2. Patients: Patients of any age and either gender
  3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Exclusion Criteria:

  1. Patients who are receiving licensed cord blood products (only)
  2. Patients who are receiving unlicensed cord blood products from other banks (only)
  3. Patients who are transplanted at non-US transplant centers
  4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Andromachi Scaradavou, MD 718-706-5207 ascaradavou@nybloodcenter.org
United States
 
 
NCT01656603
6637-01
Yes
Not Provided
Plan to Share IPD: Undecided
New York Blood Center
New York Blood Center
Not Provided
Principal Investigator: Andromachi Scaradavou, MD NY Blood Center
New York Blood Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP