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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
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Biological: intravenous injection of mesenchymal stem cells
Biological: injection of cell free media
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect and Side Effect of Mesenchymal Stem Cell in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: December 2011
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377870

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01377870     History of Changes
Other Study ID Numbers: Royn-nerve-001
Study First Received: June 19, 2011
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
multiple sclerosis mesenchymal stem cell intravenous injection

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014