CompletedNCT02283671Updated Feb 27, 2020

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

A Phase 1 interventional study of Tolerogenic Dendritic cells loaded with myelin peptides in Multiple Sclerosis and Neuromyelitis Optica, sponsored by Sara Varea. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-27.

Sponsored by Sara Varea · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Multiple Sclerosis
Neuromyelitis Optica

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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Sara Varea is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Tolerogenic dendritic cells
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

Interventions

BiologicalTolerogenic Dendritic cells loaded with myelin peptides
Somatic-cell therapy medicines application

What researchers measure

Primary outcomes

number of patients with adverse events
Time frame: after 12 weeks of follow up

Secondary outcomes

Multiple Sclerosis Functional Composite scale
Time frame: after 12 weeks of follow up
Multiple Sclerosis Spasticity Scale
Time frame: after 12 weeks of follow up
Expanded Disability Status Scale
Time frame: after 12 weeks of follow up
SF36 Health Status questionnaire
Time frame: after 12 weeks of follow up
EuroQol5D
Time frame: after 12 weeks of follow up
Changes in immunological profile
Time frame: after 12 weeks of follow up
number of disease outbreaks
Time frame: after 12 weeks of follow up

Study locations

1 site

Hospital Clinic of Barcelona
Barcelona, 08036, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02283671
Lead sponsor: Sara Varea
Responsible party: Sara Varea (Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica) — Sponsor-investigator
First posted: Nov 5, 2014
Start date: Sep 2015
Primary completion: Jul 10, 2019
Completion: Jul 10, 2019
Last update: Feb 27, 2020

Study contacts

Pablo Villoslada, MD PhD

study chair · Institut d'Investigacions Biomèdiques August Pi i Sunyer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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