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

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. Read our disclaimer for details. Identifier: NCT01235468
Recruitment Status : Withdrawn (loss of support)
First Posted : November 5, 2010
Last Update Posted : December 3, 2015
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Umbilical Cord Blood Stem Cell Transplantation Hematological Malignancies Biological: ex vivo expansion Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
Study Start Date : June 2012
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: CB expnasion
ex-vivo expansion of cord blood for transplantation
Biological: ex vivo expansion
ex-vivo expansion of cord blood for transplantation

Primary Outcome Measures :
  1. Safety [ Time Frame: 1 month ]
    Number of patients with adverse events during infusion

  2. engraftment [ Time Frame: 3 months ]
    Time to engraftment

  3. treatment-related toxicity [ Time Frame: 3 months ]
    Type and severity of adverse events after transplantation using the NCI CTC scale

  4. GVHD [ Time Frame: 1 year ]
    Number of patients with acute and chronic GVHD after transplantation

Secondary Outcome Measures :
  1. Immunological reconstruction [ Time Frame: 5 years ]
    immunological reconstruction after transplantation measured by lymphocyte number and function

  2. relapse [ Time Frame: 5 years ]
    rate of disease recurrence

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01235468

Sponsors and Collaborators
Dr. Avichai Shimoni MD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center

Responsible Party: Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, hematologist, Sheba Medical Center Identifier: NCT01235468     History of Changes
Other Study ID Numbers: SHEBA-10-7959-AN-CTIL
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Dr. Avichai Shimoni MD, Sheba Medical Center:
umbilical cord blood
ex vivo expansion