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Ended the recruitment in June 2012 for low enrollement accrual
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous mesenchymal stem cell | Experimental | A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous mesenchymal stem cells | Biological | A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study | The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales | clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis | 12 months |
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Inclusion Criteria:
Inflammatory forms of MS
Age 18-50 years
Disease duration >= 2 and >= 10 years
EDSS 3.0 - 6.5
Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
Has given informed consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Saiz, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Service, Hospital Clinic de barcelona | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25436769 | Derived | Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |