Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

Phase 1

Completed

• Conditions: Nervous System Diseases; Autoimmune Diseases; Demyelinating Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Immune System Diseases
• Interventions: Other: Autologous mesenchymal stem cells from adipose tissue.

• Registration Number: NCT01056471
• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2012-06
• Status Verified: 2015-02
• Study Completion: 2015-06
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
2. Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
3. 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.
4. Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
5. Patients who give written consent to participate in the study. -

Exclusion Criteria

1. History of current pathology or current laboratory results indicative of any severe disease.

2. Pacemaker or metallic implants that prevent MR imaging.

3. Inability to complete questionnaires.

4. Refusal to give informed consent.

5. Predicted impossibility for a biopsy of at least 30 grams of fat tissue.

6. Positive screening test for HIV, Hepatitis B or Hepatitis C.

7. History of malignancy.

8. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.

9. Body mass index> 40 kg/m2.

10. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.

11. Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Autologous mesenchymal stem cells from adipose tissue.	The dose of infused cells is 4\*10e6 cells/Kg
Low dose autologous mesenchymal cells	Autologous mesenchymal stem cells from adipose tissue.	The dose of infused cells is 10e6 cells/Kg

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells	12 months.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain