A Phase 1/2 interventional study of intravenous injection of mesenchymal stem cells and injection of cell free media in Multiple Sclerosis, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by Royan Institute · Phase 1/2, Interventional, and Treatment
Multiple sclerosis is a multifocal inflammatory disease of the central nervous system which affects young individuals and causes paralysis of the limbs, sensation, visual and sphincter problems. The disease is caused by an autoimmune mechanism, ie the immune system produces antibodies and cells which attack the self myelin antigens, causing therefore demyelination. The disease is clinically evident with relapses of neurological disability due to the dysfunction of the areas (plaques of multiple sclerosis) in which damage of myelin occurs. Disability can accumulate with time and the disease enters a progressive phase due to damage of the axons and irreversible neurodegeneration. Although, effective immunotherapies exist which downregulate the autoimmune anti-myelin reactivity and reduce the rate of relapses of MS (like Copaxone and interferons), there is no effective means today to stop the progression of disability and induce rebuilding of the destroyed myelin.Adult bone marrow derived stromal cells (MSC) were shown to induce similar (to the 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). These bone marrow derived 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 center will perform a clinical trial with intra venous transplantation of bone marrow derived mesenchymal stem cell.our purpose is to evaluate the safety and feasibility of cell transplantation after 1year following up.
In the clinical trial 30 patients with multiple sclerosis who are drug resistance will take apart.Based on inclusion and exclusion criteria patients are chosen.Bone marrow aspiration will be done for all of them under local anesthesia.Patients are randomly divided in 2 groups:case and control. Then mesenchymal stem cells which are separated and prepared will be transplanted by intravenous injection to the patients in case group and the cells which obtain from patients in control group are frozen and inject after 6 months. Patients will be followed by Evaluation of EDSS MSFC RAO Test brain and cervical MRI and quality of life questionnaire after 1th 3th 6th and 12th months after transplantation.all these tests will be done before transplantation as basic evaluation.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
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Resistance to immunomodulatory and cytotoxic drugs:
Exclusion Criteria:
15 patients with relapsing remitting multiple sclerosis who receive cell free media
Biological: injection of cell free media
Patients with relapsing remitting multiple sclerosis who underwent intravenous injection of mesenchymal stem cells
Biological: intravenous injection of mesenchymal stem cells
15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell
Also known as: stem cell transplantation
Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.
Also known as: control group
MRI metrics changes
evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
Time frame: 6 months
Brain atrophy
evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
Time frame: 12 months
number of sever relapses
evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
Time frame: 6 months
EDSS
Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
Time frame: 6 months
MSFC
Evaluation the effect of mesenchymal stem cells transplantation on MSFC
Time frame: 6 months
quality of life
Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life
Time frame: 6 months
RAO Test
Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.
Time frame: 6 months
intravenous cell transplantation
evaluation the side effect of intravenous transplantation of mesenchymal stem cell
Time frame: 6 months
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Royan Institute