Clinical Trials /

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

NCT01656603

Description:

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

Related Conditions:
  • Hematopoietic and Lymphoid System Disorder
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 6637-01
  • NCT ID: NCT01656603

Conditions

  • Infusion Reactions

Interventions

DrugSynonymsArms
unlicensed CBUunlicensed CBU

Purpose

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 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).
    

Trial Arms

NameTypeDescriptionInterventions
unlicensed CBUExperimentalThe Principal Investigators will be the transplant physicians at participating US transplant centers

    Eligibility 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.)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:N/A
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of infusion-related reactions
    Time Frame:within 48 hours of infusion
    Safety Issue:
    Description: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

    Measure:engraftment
    Time Frame:six months after transplant
    Safety Issue:
    Description:This outcome will evaluate engraftment of unlicensed cord blood units

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:New York Blood Center

    Trial Keywords

    • cord blood
    • transplantation
    • stem cells
    • adverse event

    Last Updated

    April 20, 2017