Multiple SclerosisPhase 1NCT02283671
Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
A Phase 1 study testing Tolerogenic Dendritic cells loaded with myelin peptides in people with Multiple Sclerosis and Neuromyelitis Optica, run by Sara Varea at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica
- What is being tested?
- Tolerogenic Dendritic cells loaded with myelin peptides
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to 10 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Tolerogenic Dendritic cells loaded with myelin peptides
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolerogenic Dendritic cells loaded with myelin peptidesBiological
Somatic-cell therapy medicines application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Tolerogenic Dendritic cells loaded with myelin peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with adverse events
Measured: after 12 weeks of follow up
Secondary outcomes (7)
Multiple Sclerosis Functional Composite scale
Measured: after 12 weeks of follow up
Multiple Sclerosis Spasticity Scale
Measured: after 12 weeks of follow up
Expanded Disability Status Scale
Measured: after 12 weeks of follow up
SF36 Health Status questionnaire
Measured: after 12 weeks of follow up
EuroQol5D
Measured: after 12 weeks of follow up
Changes in immunological profile
Measured: after 12 weeks of follow up
number of disease outbreaks
Measured: after 12 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startSep 2015
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Pablo Villoslada, MD PhD, Study chair, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283671
- Sponsor's protocol ID
- TolDec-EM-NMO
- Status last verified
- Feb 2020
- First submitted
- 29 Oct 2014
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Multiple Sclerosis and Neuromyelitis Optica With Regulatory Dendritic Cell: Clinical Trial Phase 1 B
- ClinicalTrials.gov ID
- NCT02283671
- Acronym / sponsor ID
- TolDec-EM-NMO
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First in human study to assess the tolerability and safety profile of treatment with dendritic cell in patients with multiple sclerosis or neuromyelitis optica.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerogenic dendritic cells | Experimental | Biological: Tolerogenic Dendritic cells loaded with myelin peptidesSomatic-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolerogenic Dendritic cells loaded with myelin peptidesSomatic-cell therapy medicines application | Biological | Tolerogenic dendritic cells |
Primary outcome
number of patients with adverse events
Time frame: after 12 weeks of follow up
7 secondary outcomes
Multiple Sclerosis Functional Composite scale
Time frame: after 12 weeks of follow up
Multiple Sclerosis Spasticity Scale
Time frame: after 12 weeks of follow up
Expanded Disability Status Scale
Time frame: after 12 weeks of follow up
SF36 Health Status questionnaire
Time frame: after 12 weeks of follow up
EuroQol5D
Time frame: after 12 weeks of follow up
Changes in immunological profile
Time frame: after 12 weeks of follow up
number of disease outbreaks
Time frame: after 12 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Villoslada, MD PhD study chair
Institut d'Investigacions Biomèdiques August Pi i Sunyer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolerogenic Dendritic cells loaded with myelin peptides in people with Multiple Sclerosis and Neuromyelitis Optica, run by Sara Varea at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adverse events (time frame: after 12 weeks of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.