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

URL:

https://clinicaltrials.gov/show/NCT01656603

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 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).

Trial Arms

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

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

February 21, 2021