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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2023-12-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Proof-of-concept, monocentric, prospective, Single-Case Experimental Design

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Randomisation to one of two treatments before alternation.

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis

Group B

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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis

Interventions

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Blood sampling

Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No