Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple Sclerosis
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.
|Multiple Sclerosis||Biological: intravenous injection of mesenchymal stem cells Biological: injection of cell free media||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect and Side Effect of Mesenchymal Stem Cell in Multiple Sclerosis|
- MRI metrics changes [ Time Frame: 6 months ]evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
- Brain atrophy [ Time Frame: 12 months ]evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
- number of sever relapses [ Time Frame: 6 months ]evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
- EDSS [ Time Frame: 6 months ]Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
- MSFC [ Time Frame: 6 months ]Evaluation the effect of mesenchymal stem cells transplantation on MSFC
- quality of life [ Time Frame: 6 months ]Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life
- RAO Test [ Time Frame: 6 months ]Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.
- intravenous cell transplantation [ Time Frame: 6 months ]evaluation the side effect of intravenous transplantation of mesenchymal stem cell
|Study Start Date:||December 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: cell free media
15 patients with relapsing remitting multiple sclerosis who receive cell free media
Biological: injection of cell free media
Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.
Other Name: control group
Experimental: mesenchymal stem cell reciepiants
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
Other Name: stem cell transplantation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377870
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of cell therapy center of Royan Institute|
|Principal Investigator:||Masoud Nabavi, MD||scientist and clinician|