Mesenchymal Stem Cells for the Treatment of MS
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)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Injection of autologous bone marrow derived mesenchymal stem cells
What it measured
Main measures
Safety of one or multiple intrathecaland intravenous injections of autologous MSC in Multiple sclerosis
One year for the first phase; 4 years for the extension phase
Safety
Other measures (2)
Clinical effects in terms of changes in the expended disability status scale (EDSS) at 3-6 month intervals
One year for the first phase; 4 years for the extension phase
Disability progressionRelapsesImmunological effects of treatment with MSC in MS
1-6 months after the first treatment with MSC
Immune response
Who could take part
MS (type not specified) · 35 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Central Nervous System Autoimm
Phase 1 · Not yet recruiting
Still running
- Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimm
Phase 1 · Withdrawn
Stopped
- Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases
Early phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Recruiting
Still running
- Neurofilament Light Chain ,Chitinase-3 Like-1 Proteins and Plasmacytoi
Status unknown
No results found
History
Started
Oct 2006
Main results due
Dec 2009
Finished
Dec 2009