Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud2 sites in 1 country30 target enrollmentJanuary 2010

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

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Autoimmune Diseases
Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Enrollment: 30
Locations: 2
Primary Endpoint: To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
•Secondary progressive MS patients with EDSS ≥ 5.5 and ≤
•Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
•Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
•Patients who give written consent to participate in the study. -

Exclusion Criteria

•History of current pathology or current laboratory results indicative of any severe disease.
•Pacemaker or metallic implants that prevent MR imaging.
•Inability to complete questionnaires.
•Refusal to give informed consent.
•Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
•Positive screening test for HIV, Hepatitis B or Hepatitis C.
•History of malignancy.
•Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
•Body mass index\> 40 kg/m
•Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.

Outcomes

Primary Outcomes

To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells

Time Frame: 12 months.

Secondary Outcomes

To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.(12 months)