Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by New York Blood Center
Information provided by (Responsible Party):
New York Blood Center Identifier:
First received: July 31, 2012
Last updated: May 16, 2013
Last verified: May 2013

July 31, 2012
May 16, 2013
February 2012
December 2019   (final data collection date for primary outcome measure)
Incidence of infusion-related reactions of the unlicensed, investigational cord blood units [ 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.
Same as current
Complete list of historical versions of study NCT01656603 on Archive Site
Incidence of transmission of infections after unrelated transplantation with investigational cord blood units [ Time Frame: six months after transplant ] [ Designated as safety issue: Yes ]
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.
Same as current
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.

Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infusion Reactions
Drug: unlicensed cord blood units
infusion of unlicensed cord blood units
Experimental: patients receiving unlicensed cord blood units
The Principal Investigators will be the transplant physicians at participating US transplant centers
Intervention: Drug: unlicensed cord blood units
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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.)
Not Provided
Contact: Andromachi Scaradavou, MD 718-706-5207
United States
New York Blood Center
New York Blood Center
Not Provided
Principal Investigator: Andromachi Scaradavou, MD NY Blood Center
New York Blood Center
May 2013

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