Clinical trial NCT01056471: Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Keywords: Multiple Sclerosis
Mesenchymal Stem Cells
Autologous
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2010-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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Primary outcomes:
measure: To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
timeFrame: 12 months.
Secondary outcomes:
measure: To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.
timeFrame: 12 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Regional Universitario Carlos Haya, Málaga, Spain.
name: Oscar Fernandez Fernandez, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen Macarena, Sevilla, Spain
name: Guillermo Izquierdo Ayuso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: