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OpenTrials
Completed

NCT Number: NCT02283671

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

First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolerogenic Dendritic cells loaded with myelin peptides

Biological

Somatic-cell therapy medicines application

Primary outcomes

  1. number of patients with adverse events

    Time frame: after 12 weeks of follow up

Secondary outcomes

  1. Multiple Sclerosis Functional Composite scale

    Time frame: after 12 weeks of follow up

  2. Multiple Sclerosis Spasticity Scale

    Time frame: after 12 weeks of follow up

  3. Expanded Disability Status Scale

    Time frame: after 12 weeks of follow up

  4. SF36 Health Status questionnaire

    Time frame: after 12 weeks of follow up

  5. EuroQol5D

    Time frame: after 12 weeks of follow up

  6. Changes in immunological profile

    Time frame: after 12 weeks of follow up

  7. number of disease outbreaks

    Time frame: after 12 weeks of follow up

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2014
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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