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

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Condition Intervention
Infusion Reactions
Drug: unlicensed cord blood units

Study Type: Interventional
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

Further study details as provided by New York Blood Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 9999
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)
Arms Assigned Interventions
Experimental: patients receiving unlicensed cord blood units
The Principal Investigators will be the transplant physicians at participating US transplant centers
Drug: unlicensed cord blood units
infusion of unlicensed cord blood units


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01656603

Contact: Andromachi Scaradavou, MD 718-706-5207

  Show 27 Study Locations
Sponsors and Collaborators
New York Blood Center
Principal Investigator: Andromachi Scaradavou, MD NY Blood Center
  More Information

Additional Information:
No publications provided

Responsible Party: New York Blood Center Identifier: NCT01656603     History of Changes
Other Study ID Numbers: 6637-01
Study First Received: July 31, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York Blood Center:
cord blood
stem cells
adverse event processed this record on March 03, 2015