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

Phase 1

Completed

• Conditions: Multiple Sclerosis; Neuromyelitis Optica

• Registration Number: NCT02283671
• Lead Sponsor: Sara Varea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-05
• Study Start: 2015-09
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of patients with adverse events	after 12 weeks of follow up

Secondary Outcome Measures

Name	Time	Method
Expanded Disability Status Scale	after 12 weeks of follow up
Multiple Sclerosis Functional Composite scale	after 12 weeks of follow up
EuroQol5D	after 12 weeks of follow up
SF36 Health Status questionnaire	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
Multiple Sclerosis Spasticity Scale	after 12 weeks of follow up

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain