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

Sara Varea

Status and phase: Completed; Phase 1

Conditions: Neuromyelitis Optica; Multiple Sclerosis

Treatments: Biological: Tolerogenic Dendritic cells loaded with myelin peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT02283671

TolDec-EM-NMO

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tolerogenic dendritic cells

Experimental group

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.

Treatment:

Biological: Tolerogenic Dendritic cells loaded with myelin peptides