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First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolerogenic dendritic cells | Experimental | Somatic-cell therapy medicines: tolerogenic dendritic cells loaded with myelin peptides. Patients will receive intravenous administration every two weeks (week 0 , 2 and 4 ) representing a total of three administrations per patient. The dose escalation will occur as expected in the absence of limiting toxicity in the previous dosage level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolerogenic Dendritic cells loaded with myelin peptides | Biological | Somatic-cell therapy medicines application |
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| Measure | Description | Time Frame |
|---|---|---|
| number of patients with adverse events | after 12 weeks of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Functional Composite scale | after 12 weeks of follow up | |
| Multiple Sclerosis Spasticity Scale | after 12 weeks of follow up | |
| Expanded Disability Status Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Villoslada, MD PhD | Institut d'Investigacions Biomèdiques August Pi i Sunyer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| 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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| after 12 weeks of follow up |
| SF36 Health Status questionnaire | after 12 weeks of follow up |
| EuroQol5D | after 12 weeks of follow up |
| Changes in immunological profile | after 12 weeks of follow up |
| number of disease outbreaks | after 12 weeks of follow up |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |