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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose autologous mesenchymal cells | Experimental | The dose of infused cells is 10e6 cells/Kg |
|
| High dose | Experimental | The dose of infused cells is 4*10e6 cells/Kg |
|
| Placebo Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous mesenchymal stem cells from adipose tissue. | Other | Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells | 12 months. |
| Measure | Description | 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Fernandez Fernandez, MD, PhD | Hospital Regional Universitario Carlos Haya, Málaga, Spain. | Study Director |
| Guillermo Izquierdo Ayuso, MD, PhD | Hospital Universitario Virgen Macarena, Sevilla, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Universitario de Málaga | Málaga | Málaga | 29010 | Spain | ||
| Hospital Universitario Virgen Macarena |
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| Label | URL |
|---|---|
| Andalusian Molecular Biology and Regenerative Medicine Centre | View source |
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| Autologous mesenchymal stem cells from adipose tissue. | Other | Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg. |
|
| Seville |
| Sevilla |
| 41004 |
| Spain |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003711 | Demyelinating Diseases |
| D009422 | Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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