Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B

Study Overview
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Brief Summary
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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.

Conditions
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Multiple Sclerosis, Neuromyelitis Optica

Intervention / Treatment
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* Biological: Tolerogenic Dendritic cells loaded with myelin peptides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with Multiple sclerosis or neuromyelitis optica diagnosed more than a year before inclusion Expanded Disability Status Scale between 3.0 and 8.5 all subtypes of multiple sclerosis or Neuromyelitis optica Multiple Sclerosis patients who have previously been offered therapeutic alternatives available in indications and either decline or that after receiving treatment for at least 6 months have had an outbreak or an increase of at least 1 point on the Expanded Disability Status Scale (EDSS) (non-responders) or who have not tolerated treatment Patients with Neuromyelitis optica (NMO) in stable immunomodulatory treatment in the past 6 months or without treatment because they are not candidates to receive it Exclusion Criteria: Corticosteroid treatment in the last 30 days Presence of an outbreak in the last month Inability to perform brain Magnetic resonance imaging (with paramagnetic contrast) Serious systemic diseases, including Hepatitis B virus, Hepatitis C Virus, and Human Immunodeficiency Virus. Uncontrolled hypertension, insulin-dependent diabetes mellitus, heart disease or kidney failure or severe respiratory Personal history of cancer or family history of known hereditary cancer patient participating in other experimental study in the last 3 months women childbearing-aged that do not use effective contraceptive methods pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tolerogenic dendritic cells<br>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. | Biological: Tolerogenic Dendritic cells loaded with myelin peptides<br>* Somatic-cell therapy medicines application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with adverse events |  | after 12 weeks of follow up | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |