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

This study has been withdrawn prior to enrollment.
(loss of support)
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center Identifier:
First received: November 2, 2010
Last updated: December 1, 2015
Last verified: December 2015
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 Intervention Phase
Umbilical Cord Blood Stem Cell Transplantation Hematological Malignancies Biological: ex vivo expansion Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Dr. Avichai Shimoni MD, Sheba Medical Center:

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

  • engraftment [ Time Frame: 3 months ]
    Time to engraftment

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

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

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

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

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CB expnasion
ex-vivo expansion of cord blood for transplantation
Biological: ex vivo expansion
ex-vivo expansion of cord blood for 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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01235468

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

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
Study First Received: November 2, 2010
Last Updated: December 1, 2015

Keywords provided by Dr. Avichai Shimoni MD, Sheba Medical Center:
umbilical cord blood
ex vivo expansion
GVHD processed this record on August 18, 2017