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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01235468
First received: November 2, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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

  • engraftment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Time to engraftment

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

  • GVHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of patients with acute and chronic GVHD after transplantation


Secondary Outcome Measures:
  • Immunological reconstruction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    immunological reconstruction after transplantation measured by lymphocyte number and function

  • relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235468

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

No publications provided

Responsible Party: Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, hematologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01235468     History of Changes
Other Study ID Numbers: SHEBA-10-7959-AN-CTIL
Study First Received: November 2, 2010
Last Updated: October 30, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
umbilical cord blood
ex vivo expansion
engraftment
GVHD

Additional relevant MeSH terms:
Neoplasms
Hematologic Diseases
Hematologic Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 28, 2014