Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01377870
First received: June 19, 2011
Last updated: April 24, 2014
Last verified: August 2010

June 19, 2011
April 24, 2014
December 2011
March 2014   (final data collection date for primary outcome measure)
  • MRI metrics changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
  • Brain atrophy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
  • number of sever relapses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
  • EDSS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
  • MSFC [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation the effect of mesenchymal stem cells transplantation on MSFC
Same as current
Complete list of historical versions of study NCT01377870 on ClinicalTrials.gov Archive Site
  • quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life
  • RAO Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.
  • intravenous cell transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    evaluation the side effect of intravenous transplantation of mesenchymal stem cell
Same as current
Not Provided
Not Provided
 
Evaluation of Autologous Mesenchymal Stem Cell Transplantation (Effects and Side Effects) in Multiple Sclerosis
Effect and Side Effect of Mesenchymal Stem Cell 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • 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
  • 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
  • Placebo Comparator: cell free media
    15 patients with relapsing remitting multiple sclerosis who receive cell free media
    Intervention: Biological: injection of cell free media
  • Experimental: mesenchymal stem cell reciepiants
    Patients with relapsing remitting multiple sclerosis who underwent intravenous injection of mesenchymal stem cells
    Intervention: Biological: intravenous injection of mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Both gender
  • Age: 18-55years
  • Duration of disease: 2-10 years
  • Relapsing remitting with drug resistance
  • EDSS: 3-6.5
  • Resistance to immunomodulatory and cytotoxic drugs:

    • At least 1-2 sever relapse during 1 year drug treatment
    • At least increase 1 point of EDSS during 1 year drug treatment
  • Secondary progressive or relapsing multiple sclerosis
  • Primary progressive MS with relapse or GAD positive enhancement
  • Secondary progressive MS with relapse
  • Secondary progressive MS without relapse:progression of disease with 1 point increase of EDSS during last 18 months

Exclusion Criteria:

  • Pregnancy positive test
  • Under treatment with cytotoxic drugs at the same time or during last 3 months
  • Under treatment with immunomodulatory drugs at the same time or during last month
  • Relapse of disease 30 days or less than 30 days before transplantation
  • Primary progressive MS with out relapse or GAD positive enhancement
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01377870
Royn-nerve-001
Yes
Royan Institute
Royan Institute
Not Provided
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
Royan Institute
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP