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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis (MS) Biological: Mesenchymal stem cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IT- Treated
Injection to IT
Biological: Mesenchymal stem cells
Experimental: IV - Treated
Injection to IV
Biological: Mesenchymal stem cells
Experimental: IT and IV Treated
Injection to IT and IV
Biological: Mesenchymal stem cells



Primary Outcome Measures :
  1. Brain MRI [ Time Frame: Change from baseline brain MRI at12 months following treatment ]
  2. Immunological Response [ Time Frame: Change from baseline immunological response at12 months following treatment ]

Secondary Outcome Measures :
  1. Neurological function [ Time Frame: Change from baseline in EDSS score at12 months following treatment ]
    EDSS - Expanded Disability Status Scale

  2. Electrophysiological tests [ Time Frame: At baseline and at 6 and 12 months following treatmentChange from baseline electrophysiological tests at12 months following treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02166021


Contacts
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Contact: Dimitrios Karussis, MD 02-6776939 karus@cc.huji.ac.il

Locations
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Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Dimitrios Karussis, MD         
Sponsors and Collaborators
Dimitrios Karussis

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Responsible Party: Dimitrios Karussis, Head of The Center for Multiple Sclerosis & Laboratory of Neuroimmunology, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02166021     History of Changes
Other Study ID Numbers: MSCMS-001-IL
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by Dimitrios Karussis, Hadassah Medical Organization:
Multiple Sclerosis (MS)
Stem Cells

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases