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

This study is currently recruiting participants.
Verified August 2010 by Royan Institute
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01377870
First received: June 19, 2011
Last updated: March 13, 2013
Last verified: August 2010
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377870

Contacts
Contact: Nasser Aghdami, MD,PhD (98)2122416300 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (98)2122339600 leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD     (98)2122426300     nasser.aghdami@royaninstitute.org    
Contact: Leila Arab, MD     (98)2122339800     leara91@gmail.com    
Principal Investigator: Leila Arab, MD            
Sub-Investigator: Soura Mardpour, MSc            
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: nasser Aghdami, MD,PhD     (+98)2122339913     nasser.aghdami@royaninstitute.org    
Contact: Leila Arab, MD     (+98)2122339951     leara91@gmail.com    
Principal Investigator: leila Arab, MD            
Sub-Investigator: Soura Mardpour, MSc            
Sub-Investigator: Seyedeh Esmat Hosseini, BSc            
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:
Related Info  This link exits the ClinicalTrials.gov site

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: March 13, 2013
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
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013