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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
- 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)
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
|Principal Investigator:||Dimitrios Karussis, Prof.||Hadassah Medical Organization|