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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 : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
New York Blood Center

Tracking Information
First Submitted Date  ICMJE July 31, 2012
First Posted Date  ICMJE August 3, 2012
Last Update Posted Date March 23, 2023
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2015)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2015)		 engraftment [ Time Frame: six months after transplant ]
This outcome will evaluate engraftment of unlicensed cord blood units
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2012)		 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
Official Title  ICMJE 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
Brief Summary This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Detailed Description

The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (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 cord blood (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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infusion Reactions
Intervention  ICMJE Biological: unlicensed CBU
infusion of unlicensed cord blood units
Study Arms  ICMJE Experimental: unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
Intervention: Biological: unlicensed CBU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2012)		 9999
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dorothy Sung 718-706-5202 dsung@nybc.org
Contact: Emeline Masson Frenet 718-752-4710 ncbp@nybc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01656603
Other Study ID Numbers  ICMJE 6637-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party New York Blood Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE New York Blood Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandra Jimenez, MD NY Blood Center
PRS Account New York Blood Center
Verification Date March 2023

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