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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056471

Enrollment

Registered

2010-01-26

Start date

2010-01-31

Completion date

2015-06-30

Last updated

2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Multiple Sclerosis, Mesenchymal Stem Cells, Autologous

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.

Interventions

OTHERAutologous mesenchymal stem cells from adipose tissue.

Intravenous infusion of autologous mesenchymal stem cells.Dose:4\*10e6 cells/Kg.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \-

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026