Mesenchymal Stem Cell Transplantation in MS

Study Overview
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Brief Summary
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The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

Official Title
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Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Biological: autologous mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inflammatory forms of MS Relapsing-remitting MS (RRMS) patients Secondary progressive MS (SPMS) patients with continued relapses Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding) Age 18-50 years Disease duration >= 2 and >= 10 years EDSS 3.0 - 6.5 Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by: Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression >= 1 moderate-severe relapses in past 18 months >= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium) >= 1 new T2 lesion For PPMS only, >= 1 Gadolinium enhancing lesions Has given informed consent to participate in the study. Exclusion Criteria: SPMS without ongoing relapses PPMS without positive CSF or Gadolinium enhancing lesions <= 3 months since treatment with any immunosuppressive therapy <=1 month since last treatment with interferon-B or glatiramer acetate Corticosteroid treatment <= 30 days Relapse <= 60 days History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C Any metallic or electronic device that precludes from undergoing MRI Pregnancy or lactation Current treatment with an investigational therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous mesenchymal stem cell<br>A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months | Biological: autologous mesenchymal stem cells<br>* A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study | The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales | clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis