Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
NCT ID: NCT01056471
Last Updated: 2015-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2010-01-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose autologous mesenchymal cells
The dose of infused cells is 10e6 cells/Kg
Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
High dose
The dose of infused cells is 4\*10e6 cells/Kg
Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells.Dose:4\*10e6 cells/Kg.
Placebo Control
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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
\-
18 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Oscar Fernandez Fernandez, MD, PhD
Role: STUDY_DIRECTOR
Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Guillermo Izquierdo Ayuso, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena, Sevilla, Spain
Locations
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Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Countries
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Related Links
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Andalusian Molecular Biology and Regenerative Medicine Centre
Other Identifiers
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CMM/EM/2008
Identifier Type: -
Identifier Source: org_study_id
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