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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mesenchymal Stem Cells for Multiple Sclerosis

NCT01730547

Multiple Sclerosis

COMPLETED PHASE1/PHASE2

Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis

NCT06360861

Multiple Sclerosis Secondary-Progressive Multiple Sclerosis Mesenchymal Stem Cells

COMPLETED PHASE1

Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Treatment of Primary Progressive Multiple Sclerosis

NCT06592703

Multiple Sclerosis

RECRUITING PHASE1

Mesenchymal Stem Cells for the Treatment of MS

NCT00781872

Multiple Sclerosis

COMPLETED PHASE1/PHASE2

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

NCT00813969

Relapsing-Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cell free media

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

Group Type PLACEBO_COMPARATOR

injection of cell free media

Intervention Type BIOLOGICAL

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

mesenchymal stem cell reciepiants

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

Group Type EXPERIMENTAL

intravenous injection of mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intravenous injection of mesenchymal stem cells

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

stem cell transplantation control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No