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

NCT02283671 | Completed Phase 1

• 1 other identifier: TolDec-EM-NMO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• number of patients with adverse events

  after 12 weeks of follow up

Secondary Outcomes (7)

• Multiple Sclerosis Functional Composite scale

  after 12 weeks of follow up

• Multiple Sclerosis Spasticity Scale

  after 12 weeks of follow up

• Expanded Disability Status Scale

  after 12 weeks of follow up

• SF36 Health Status questionnaire

  after 12 weeks of follow up

• EuroQol5D

  after 12 weeks of follow up

Study Arms (1)

Tolerogenic dendritic cells

EXPERIMENTAL

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

Tolerogenic Dendritic cells loaded with myelin peptides BIOLOGICAL

Somatic-cell therapy medicines application

Tolerogenic dendritic cells

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with Multiple sclerosis or neuromyelitis optica
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Varea: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Pablo Villoslada, MD PhD

  Institut d'Investigacions Biomèdiques August Pi i Sunyer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2015
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

ES (1)