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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

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

Condition or disease Intervention/treatment Phase
Infusion Reactions Biological: unlicensed CBU Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9999 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2012
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. engraftment [ Time Frame: six months after transplant ]
    This outcome will evaluate engraftment of unlicensed cord blood units


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656603


Contacts
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Contact: Dorothy Sung 718-706-5202 dsung@nybc.org
Contact: Emeline Masson Frenet 718-752-4710 ncbp@nybc.org

Locations
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Sponsors and Collaborators
New York Blood Center
Investigators
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Principal Investigator: Alexandra Jimenez, MD NY Blood Center
More Information
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Additional Information:

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Responsible Party: New York Blood Center
ClinicalTrials.gov Identifier: NCT01656603    
Other Study ID Numbers: 6637-01
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by New York Blood Center:
cord blood
transplantation
stem cells
adverse event