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

Primary Purpose

Multiple Sclerosis, Neuromyelitis Optica

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Tolerogenic Dendritic cells loaded with myelin peptides
Sponsored by
Sara Varea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tolerogenic dendritic cells

Arm Description

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.

Outcomes

Primary Outcome Measures

number of patients with adverse events

Secondary Outcome Measures

Multiple Sclerosis Functional Composite scale
Multiple Sclerosis Spasticity Scale
Expanded Disability Status Scale
SF36 Health Status questionnaire
EuroQol5D
Changes in immunological profile
number of disease outbreaks

Full Information

First Posted
October 29, 2014
Last Updated
February 26, 2020
Sponsor
Sara Varea
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1. Study Identification

Unique Protocol Identification Number
NCT02283671
Brief Title
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Neuromyelitis Optica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tolerogenic dendritic cells
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Tolerogenic Dendritic cells loaded with myelin peptides
Intervention Description
Somatic-cell therapy medicines application
Primary Outcome Measure Information:
Title
number of patients with adverse events
Time Frame
after 12 weeks of follow up
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Functional Composite scale
Time Frame
after 12 weeks of follow up
Title
Multiple Sclerosis Spasticity Scale
Time Frame
after 12 weeks of follow up
Title
Expanded Disability Status Scale
Time Frame
after 12 weeks of follow up
Title
SF36 Health Status questionnaire
Time Frame
after 12 weeks of follow up
Title
EuroQol5D
Time Frame
after 12 weeks of follow up
Title
Changes in immunological profile
Time Frame
after 12 weeks of follow up
Title
number of disease outbreaks
Time Frame
after 12 weeks of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Villoslada, MD PhD
Organizational Affiliation
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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