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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283671
• Other study ID #: TolDec-EM-NMO
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: July 10, 2019

Study information

• Verified date: February 2020
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica
• Sclerosis

Intervention

Biological:
• Tolerogenic Dendritic cells loaded with myelin peptides
Somatic-cell therapy medicines application

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with adverse events		after 12 weeks of follow up
Secondary	Multiple Sclerosis Functional Composite scale		after 12 weeks of follow up
Secondary	Multiple Sclerosis Spasticity Scale		after 12 weeks of follow up
Secondary	Expanded Disability Status Scale		after 12 weeks of follow up
Secondary	SF36 Health Status questionnaire		after 12 weeks of follow up
Secondary	EuroQol5D		after 12 weeks of follow up
Secondary	Changes in immunological profile		after 12 weeks of follow up
Secondary	number of disease outbreaks		after 12 weeks of follow up