Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01056471 |
Recruitment Status
:
Completed
First Posted
: January 26, 2010
Last Update Posted
: August 7, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autoimmune Diseases Immune System Diseases Demyelinating Diseases Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System | Other: Autologous mesenchymal stem cells from adipose tissue. | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | January 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Low dose autologous mesenchymal cells
The dose of infused cells is 10e6 cells/Kg
|
Other: Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
|
Experimental: High dose
The dose of infused cells is 4*10e6 cells/Kg
|
Other: Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
|
No Intervention: Placebo Control |
- To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 12 months. ]
- To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
- Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
- 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.
- Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
- Patients who give written consent to participate in the study. -
Exclusion Criteria:
- History of current pathology or current laboratory results indicative of any severe disease.
- Pacemaker or metallic implants that prevent MR imaging.
- Inability to complete questionnaires.
- Refusal to give informed consent.
- Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
- Positive screening test for HIV, Hepatitis B or Hepatitis C.
- History of malignancy.
- Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
- Body mass index> 40 kg/m2.
- Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
-
Pregnancy or lactation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056471
Spain | |
Hospital Regional Universitario de Málaga | |
Málaga, Spain, 29010 | |
Hospital Universitario Virgen Macarena | |
Sevilla, Spain, 41004 |
Study Director: | Oscar Fernandez Fernandez, MD, PhD | Hospital Regional Universitario Carlos Haya, Málaga, Spain. | |
Principal Investigator: | Guillermo Izquierdo Ayuso, MD, PhD | Hospital Universitario Virgen Macarena, Sevilla, Spain |
Additional Information:
Responsible Party: | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud |
ClinicalTrials.gov Identifier: | NCT01056471 History of Changes |
Other Study ID Numbers: |
CMM/EM/2008 |
First Posted: | January 26, 2010 Key Record Dates |
Last Update Posted: | August 7, 2015 |
Last Verified: | February 2015 |
Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Multiple Sclerosis Mesenchymal Stem Cells Autologous |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Nervous System Diseases Autoimmune Diseases Immune System Diseases Multiple Sclerosis, Chronic Progressive Demyelinating Diseases |
Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Pathologic Processes Leukoencephalopathies Brain Diseases Central Nervous System Diseases |