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Optimal Administration Mode of Autologous Mesenchymal Bone Marrow Stem Cells in Active and Progressive Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02166021
Recruitment Status : Unknown
Verified June 2016 by Dimitrios Karussis, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dimitrios Karussis, Hadassah Medical Organization

May 20, 2014
June 18, 2014
June 8, 2016
January 2015
March 2017   (Final data collection date for primary outcome measure)
  • Brain MRI [ Time Frame: Change from baseline brain MRI at12 months following treatment ]
  • Immunological Response [ Time Frame: Change from baseline immunological response at12 months following treatment ]
Same as current
Complete list of historical versions of study NCT02166021 on ClinicalTrials.gov Archive Site
  • Neurological function [ Time Frame: Change from baseline in EDSS score at12 months following treatment ]
    EDSS - Expanded Disability Status Scale
  • Electrophysiological tests [ Time Frame: At baseline and at 6 and 12 months following treatmentChange from baseline electrophysiological tests at12 months following treatment ]
Same as current
Not Provided
Not Provided
 
Optimal Administration Mode of Autologous Mesenchymal Bone Marrow Stem Cells in Active and Progressive Multiple Sclerosis
Phase IIA Trial to Investigate the Optimal Way of Administration (Based on the Immunological, Clinical and Neuroradiological Effects) of Autologous Mesenchymal Bone Marrow Stem Cells (MSC) in Active and Progressive Multiple Sclerosis (MS)
The purpose of this study is to to evaluate the optimal dosage and the way of administration of autologous mesenchymal bone marrow stem cells (MSC) either in maximal proximity of the lesions in the CNS or by intrathecal injection to the CSF.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis (MS)
Biological: Mesenchymal stem cells
  • Experimental: IT- Treated
    Injection to IT
    Intervention: Biological: Mesenchymal stem cells
  • Experimental: IV - Treated
    Injection to IV
    Intervention: Biological: Mesenchymal stem cells
  • Experimental: IT and IV Treated
    Injection to IT and IV
    Intervention: Biological: Mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
36
Same as current
March 2018
March 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Consenting patients fulfilling the Poser's clinical criteria for definite MS
  2. Age: 25-65, males and females
  3. Duration of disease: >3 years
  4. Progressive form of MS (RPMS, SPMS)
  5. EDSS score of 3.0 - 6.5
  6. Failure to the currently available, registered - first and second line immunomodulatory treatments
  7. Evidence for new activity of MS during the 3 months before the injection of MSC.

Exclusion Criteria:

  1. Patients who were treated with cytotoxic medications during the last 3 months prior to the inclusion.
  2. Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
  3. Patients with active infections
  4. Patients with severe cognitive decline or inability to understand and sign the informed consent
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02166021
MSCMS-001-IL
No
Not Provided
Not Provided
Dimitrios Karussis, Hadassah Medical Organization
Dimitrios Karussis
Not Provided
Not Provided
Hadassah Medical Organization
June 2016

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