CompletedInterventionalPhase 1Phase 2Updated May 4, 2015
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B | NCT02283671 | Trialant
CompletedInterventionalPhase 1Updated Feb 27, 2020
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
ClinicalTrials.gov ID
NCT02283671
Lead Sponsor
Sara VareaOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
20Actual
Last Update Posted
Feb 27, 2020Actual
Start Date
Sep 2015
Primary Completion Date
Jul 10, 2019Actual
Completion Date
Jul 10, 2019Actual
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.
Multiple Sclerosis
Neuromyelitis Optica
Tolerogenic Dendritic cells loaded with myelin peptides
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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