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

NCT01377870 | Completed Phase 1 DMC

• 1 other identifier: Royn-nerve-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis mesenchymal stem cell intravenous injection

Outcome Measures

Primary Outcomes (5)

• MRI metrics changes

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

  6 months

• Brain atrophy

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

  12 months

• number of sever relapses

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

  6 months

• EDSS

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

  6 months

• MSFC

  Evaluation the effect of mesenchymal stem cells transplantation on MSFC

  6 months

Secondary Outcomes (3)

• quality of life

  6 months

• RAO Test

  6 months

• intravenous cell transplantation

  6 months

Study Arms (2)

cell free media

PLACEBO COMPARATOR

15 patients with relapsing remitting multiple sclerosis who receive cell free media

Biological: injection of cell free media

mesenchymal stem cell reciepiants

EXPERIMENTAL

Patients with relapsing remitting multiple sclerosis who underwent intravenous injection of mesenchymal stem cells

Biological: intravenous injection of mesenchymal stem cells

Interventions

intravenous injection of mesenchymal stem cells BIOLOGICAL

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

Also known as: stem cell transplantation

mesenchymal stem cell reciepiants

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.

Also known as: control group

cell free media

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Stem Cell Transplantation; Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hamid Gourabi, PhD

  head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of cell therapy center of Royan Institute

  STUDY DIRECTOR

• Masoud Nabavi, MD

  scientist and clinician

  PRINCIPAL INVESTIGATOR

• Leila Arab, MD

  Department of regenerative medicine,Royan Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2011
• First Posted: June 21, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 7, 2018

Record last verified: 2010-08

Locations

IR (1)