Effects of Single Plasma Exchange and Double Filtration Plasmapheresis (DFPP) on Peripheral Lymphocyte Phenotypes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (LYMPHOARESIS)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Early Phase 1

Conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Treatments: Biological: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04742374

2020-A02879-30 (Other Identifier)

NIMAO/2020-01/OM001

Details and patient eligibility

About

CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) without pathogenic antibodies and stable under therapeutic plasmapheresis with one session every 2-3 weeks for at least two months.
• Patients who have given free written informed consent.
• Patients who have signed the consent form.
• Patients affiliated to or beneficiaries of a health insurance scheme.
• Adult patients (≥18 ans).
• Healthy subjects of the same age and sex

Exclusion criteria

• Patients Under the age of 18.
• Patients under immunosuppressive treatment for less than 3 months.
• Patients participating in Category 1 research involving human subjects.
• Patients in an exclusion period determined by another study.
• Patients under legal protection, guardianship or curatorship.
• Patients unable to express consent.
• Patients for whom it is impossible to give informed information.
• Pregnant, parturient or breastfeeding patients.
• Healthy subject with chronic pathology or drug treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Group A

Experimental group

Description:

Patients alternating single plasma exchange followed by double filtration plasmapheresis etc.

Treatment:

Biological: Blood sampling

Group B

Experimental group

Description:

Patients alternating double filtration plasmapheresis followed by single plasma exchange etc.

Treatment:

Biological: Blood sampling