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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056471
• Other study ID #: CMM/EM/2008
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 25, 2010
• Last updated: August 4, 2015
• Start date: January 2010
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Demyelinating Autoimmune Diseases, CNS
• Demyelinating Diseases
• Immune System Diseases
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Nervous System Diseases

Intervention

Other:
• Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
• Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells		12 months.	Yes
Secondary	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	Yes

External Links

•   Andalusian Molecular Biology and Regenerative Medicine Centre