Multiple Sclerosis, Neuromyelitis Optica
Conditions
Brief summary
First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
Interventions
BIOLOGICALTolerogenic Dendritic cells loaded with myelin peptides
Somatic-cell therapy medicines application
Sponsors
Sara Varea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with adverse events | after 12 weeks of follow up |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Multiple Sclerosis Functional Composite scale | 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 |
| EuroQol5D | after 12 weeks of follow up |
Countries
Spain
Outcome results
None listed