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Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

Primary Purpose

Umbilical Cord Blood, Stem Cell Transplantation, Hematological Malignancies

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ex vivo expansion
Sponsored by
Dr. Avichai Shimoni MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Umbilical Cord Blood focused on measuring umbilical cord blood, ex vivo expansion, engraftment, GVHD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18 years
  • hematological malignancy
  • standard indication for allogeneic transplantation
  • expected survival time over 12 weeks
  • no related or unrelated donor
  • availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Prior allogeneic transplantation
  • Pregnant or nursing women
  • Positive serology for hepatitis B or C
  • HIV positive
  • Left ventricular ejection fraction < 50%
  • DLCO < 50%
  • Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
  • Treatment with other investigational drugs within 4 weeks of enrolling in this protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CB expnasion

    Arm Description

    ex-vivo expansion of cord blood for transplantation

    Outcomes

    Primary Outcome Measures

    Safety
    Number of patients with adverse events during infusion
    engraftment
    Time to engraftment
    treatment-related toxicity
    Type and severity of adverse events after transplantation using the NCI CTC scale
    GVHD
    Number of patients with acute and chronic GVHD after transplantation

    Secondary Outcome Measures

    Immunological reconstruction
    immunological reconstruction after transplantation measured by lymphocyte number and function
    relapse
    rate of disease recurrence

    Full Information

    First Posted
    November 2, 2010
    Last Updated
    December 1, 2015
    Sponsor
    Dr. Avichai Shimoni MD
    Collaborators
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01235468
    Brief Title
    Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
    Official Title
    Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    loss of support
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr. Avichai Shimoni MD
    Collaborators
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
    Detailed Description
    Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Umbilical Cord Blood, Stem Cell Transplantation, Hematological Malignancies
    Keywords
    umbilical cord blood, ex vivo expansion, engraftment, GVHD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CB expnasion
    Arm Type
    Experimental
    Arm Description
    ex-vivo expansion of cord blood for transplantation
    Intervention Type
    Biological
    Intervention Name(s)
    ex vivo expansion
    Intervention Description
    ex-vivo expansion of cord blood for transplantation
    Primary Outcome Measure Information:
    Title
    Safety
    Description
    Number of patients with adverse events during infusion
    Time Frame
    1 month
    Title
    engraftment
    Description
    Time to engraftment
    Time Frame
    3 months
    Title
    treatment-related toxicity
    Description
    Type and severity of adverse events after transplantation using the NCI CTC scale
    Time Frame
    3 months
    Title
    GVHD
    Description
    Number of patients with acute and chronic GVHD after transplantation
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Immunological reconstruction
    Description
    immunological reconstruction after transplantation measured by lymphocyte number and function
    Time Frame
    5 years
    Title
    relapse
    Description
    rate of disease recurrence
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 18 years hematological malignancy standard indication for allogeneic transplantation expected survival time over 12 weeks no related or unrelated donor availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status >2 Prior allogeneic transplantation Pregnant or nursing women Positive serology for hepatitis B or C HIV positive Left ventricular ejection fraction < 50% DLCO < 50% Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arnon Nagler, MD
    Organizational Affiliation
    Chaim Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

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