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Mesenchymal Stem Cells for the Treatment of MS

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ClinicalTrials.gov Identifier: NCT00781872
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : March 29, 2021
Information provided by (Responsible Party):
Dimitrios Karussis, Hadassah Medical Organization

Brief Summary:

Although, effective immunotherapies for MS exist which downregulate the anti-myelin reactivity and reduce the rate of relapses of the disease, there is no effective means today to stop the progression of disability and induce remyelination. Neuronal stem cells were shown to possess the ability to restore neuronal activity and produce new neurons through transdifferentiation. Various other types of stem cells were tested in animal models with promising results, revealing a potential for restoration of the neurological function in neuroimmune and neurodegenerative conditions. Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to neuronal stem cells) immunomodulatory and neuroregenerative effects and were shown in our laboratory to induce neuroprotection in the animal model of chronic experimental autoimmune encephalomyelitis (EAE). MSCs offer practical advantages for clinical therapeutic applications, since they can be obtained from the adult bone marrow and therefore the patient can be the donor for himself, without any danger for rejection of the cells. In addition, MSCs carry a safer profile and are less prone to malignant transformation.

Our initial clinical experience with 10 patients with ALS and 10 with multiple sclerosis show that intravenous and intrathecal administration of MSCs is feasible and safe.

In this study we propose an explorative protocol with the injection of MSCs (both intrathecally and intravenously) in patients with MS, in an effort to prevent further neurodegeneration through neuroprotective mechanisms and induce neuroregeneration and restoration of neuronal function.

The primary endpoint will be to further evaluate the safety and feasibility of the treatment with MSC infusions, in MS patients. Additionally, the migration ability of the transplanted cells will be evaluated by tagging MSCs with the superparamagnetic iron oxide particle (Feridex) for detection by MRI. Clinically the patients will be followed by monthly evaluations of the MS functional rating scale (EDSS) scale. The MRI, will be also used to evaluate changes in the total volume of lesions in the brain and the degree of atrophy.

Significance: This project may provide information for possible therapeutic uses of this type of bone marrow adult stem cells in MS but may also serve as a pilot platform and pave the path for future applications of various types of stem cells in neurodegerative diseases, in general.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: Injection of autologous bone marrow derived mesenchymal stem cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Explorative Trial to Investigate the Safety and Clinical Effects of Autologous Mesenchymal Bone Marrow Stem Cells (MSC) Following Their Intrathecal and Intravenous Administration in Severe Cases of Multiple Sclerosis (MS)
Actual Study Start Date : October 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously
Intrathecal and intravenous treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously in patients with active multiple sclerosis, failures to respond to other treatments
Biological: Injection of autologous bone marrow derived mesenchymal stem cells
60 million cells intrathecally (approximately 1 million cells per Kg of body weight) and 20 million cells intravenously
Other Name: Mesenchymal stem cells of bone marrow

Primary Outcome Measures :
  1. Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis [ Time Frame: One year for the first phase; 4 years for the extension phase ]
    Appearance of adverse events during the 1-4 years of follow up after one or multiple treatments with MSC

Secondary Outcome Measures :
  1. Clinical effects in terms of changes in the expended disability status scale (EDSS) at 3-6 month intervals [ Time Frame: One year for the first phase; 4 years for the extension phase ]
    The changes in EDSS score and relapses will be recorded at 3-6 month intervals in patients treated with 1-8 treatments of MSC interthecally and intravenously

  2. Immunological effects of treatment with MSC in MS [ Time Frame: 1-6 months after the first treatment with MSC ]
    Changes in the proportion of T-regs (CD4/CD25/FoxP3) and of activated cells (CD69) and the proliferation ability of lymphocytes in patients' peripheral blood at 1 day, 1, 3 and 6 months following the first treatment with MSC (compared to baseline)

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Consenting patients fulfilling the Poser's clinical criteria for definite MS
  2. Age: 35-65, males and females
  3. Duration of disease: >5 years
  4. Failure to the currently available -registered- for MS immunomodulatory treatments (ie interferons, Copaxone, immunosuppression): the lack of response to (at least two) of these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the EDSS score during the last year or the appearance of at least two major relapses of MS during the same period of time (under treatment).

Exclusion criteria

  1. Patients who were treated with cytotoxic medications (cyclophosphamide, Mitoxanthrobne etc) 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): NCT00781872

Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Dimitrios Karussis, Prof. Hadassah Medical Organization
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dimitrios Karussis, Head of The Center for Multiple Sclerosis & Unit of Neuroimmunology, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00781872    
Other Study ID Numbers: MS22MSC-HMO-CTIL
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Keywords provided by Dimitrios Karussis, Hadassah Medical Organization:
multiple sclerosis (MS)
bone marrow stromal cells
stem cells
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases