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

March 6, 2018 updated by: Royan Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI metrics changes
Time Frame: 6 months
evaluate the effect of mesenchymal stem cell transplantation on number of GD positive lesions.
6 months
Brain atrophy
Time Frame: 12 months
evaluate the effect of mesenchymal stem cell transplantation to improve brain atrophy
12 months
number of sever relapses
Time Frame: 6 months
evaluation the effect of mesenchymal stem cell transplantation on number of sever relapses
6 months
EDSS
Time Frame: 6 months
Evaluation the effect of mesenchymal stem cells on progression of disease based on EDSS
6 months
MSFC
Time Frame: 6 months
Evaluation the effect of mesenchymal stem cells transplantation on MSFC
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 6 months
Evaluation the effect of mesenchymal stem cell transplantation on patients quality of life
6 months
RAO Test
Time Frame: 6 months
Evaluation the effect of mesenchymal stem cell transplantation on RAO Test.
6 months
intravenous cell transplantation
Time Frame: 6 months
evaluation the side effect of intravenous transplantation of mesenchymal stem cell
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Principal Investigator: Leila Arab, MD, Department of regenerative medicine,Royan Institute
  • Study Director: Nasser Aghdami, MD,PhD, Head of cell therapy center of Royan Institute
  • Principal Investigator: Masoud Nabavi, MD, scientist and clinician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 19, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royn-nerve-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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