Skip to main content
OpenTrials
Completed

NCT Number: NCT01377870

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous injection of mesenchymal stem cells

Biological

15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell

Other names: stem cell transplantation

injection of cell free media

Biological

Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.

Other names: control group

Primary outcomes

  1. MRI metrics changes

    Time frame: 6 months

    evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.

  2. Brain atrophy

    Time frame: 12 months

    evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy

  3. number of sever relapses

    Time frame: 6 months

    evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses

  4. EDSS

    Time frame: 6 months

    Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS

  5. MSFC

    Time frame: 6 months

    Evaluation the effect of mesenchymal stem cells transplantation on MSFC

Secondary outcomes

  1. quality of life

    Time frame: 6 months

    Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life

  2. RAO Test

    Time frame: 6 months

    Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.

  3. intravenous cell transplantation

    Time frame: 6 months

    evaluation the side effect of intravenous transplantation of mesenchymal stem cell

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Effect and Side Effect of Mesenchymal Stem Cell in Multiple Sclerosis

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 21, 2011
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.