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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02283671
• Date of registration: 29/10/2014
• Prospective Registration: Yes
• Primary sponsor: Sara Varea
• Public title: Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
• Date of first enrolment: September 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02283671
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Spain

Contacts

• Name: Pablo Villoslada, MD PhD
• Affiliation: Institut d'Investigacions Biomèdiques August Pi i Sunyer

Key inclusion & exclusion 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

- pregnant or breastfeeding women



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica

Multiple Sclerosis

Intervention(s)

Biological: Tolerogenic Dendritic cells loaded with myelin peptides

Primary Outcome(s)

number of patients with adverse events [Time Frame: after 12 weeks of follow up]

Secondary Outcome(s)

SF36 Health Status questionnaire [Time Frame: after 12 weeks of follow up]

EuroQol5D [Time Frame: after 12 weeks of follow up]

Multiple Sclerosis Functional Composite scale [Time Frame: after 12 weeks of follow up]

Changes in immunological profile [Time Frame: after 12 weeks of follow up]

Expanded Disability Status Scale [Time Frame: after 12 weeks of follow up]

number of disease outbreaks [Time Frame: after 12 weeks of follow up]

Multiple Sclerosis Spasticity Scale [Time Frame: after 12 weeks of follow up]

Secondary ID(s)

TolDec-EM-NMO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors