Status:
COMPLETED
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
Lead Sponsor:
Sara Varea
Conditions:
Multiple Sclerosis
Neuromyelitis Optica
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02283671
Start Date
September 1 2015
End Date
July 10 2019
Last Update
February 27 2020
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Spain, 08036