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

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ClinicalTrials.gov Identifier: NCT02283671
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Neuromyelitis Optica Biological: Tolerogenic Dendritic cells loaded with myelin peptides Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Tolerogenic dendritic cells

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
Somatic-cell therapy medicines application




Primary Outcome Measures :
  1. number of patients with adverse events [ Time Frame: after 12 weeks of follow up ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283671


Contacts
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Contact: Pablo Villoslada, MD PhD +34932275400 ext 4802 PVILLOSL@clinic.ub.es
Contact: Sara Varea Latorre, BSc +34932275400 ext 3343 svarea@clinic.ub.es

Locations
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Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Pablo Villoslada, MD PhD    +34932275400 ext 4802    PVILLOSL@clinic.ub.es   
Contact: Irati Zubizarreta, MD       zubirati27@gmail.com   
Sponsors and Collaborators
Sara Varea
Investigators
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Study Chair: Pablo Villoslada, MD PhD Institut d'Investigacions Biomèdiques August Pi i Sunyer

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Responsible Party: Sara Varea, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02283671     History of Changes
Other Study ID Numbers: TolDec-EM-NMO
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Neuromyelitis Optica
Pathologic Processes
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