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

NCT ID: NCT02283671

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-07-10

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.

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tolerogenic Dendritic cells loaded with myelin peptides

Intervention Type: BIOLOGICAL

Somatic-cell therapy medicines application

Interventions

Tolerogenic Dendritic cells loaded with myelin peptides

Somatic-cell therapy medicines application

Intervention Type: BIOLOGICAL

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
• pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sara Varea

OTHER

Sponsor Role: lead

Responsible Party

Sara Varea

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pablo Villoslada, MD PhD

Role: STUDY_CHAIR

Institut d'Investigacions Biomèdiques August Pi i Sunyer

Locations

Hospital Clinic of Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

TolDec-EM-NMO

Identifier Type: -

Identifier Source: org_study_id