An interventional study of Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany) in Neurological Autoimmune Diseases, sponsored by University Medical Center Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by University Medical Center Mainz · Not applicable, Interventional, and Treatment
In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases. In the subgroup analysis of MS patients also the EDSS was evaluated. In addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.
Plasma exchange (PE) and immunoadsorption (IA) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (Guillain-Barré-Syndrom) or autoimmune encephalitis. This prospective controlled monocentric observational study of patients treated with either tryptophan IA or PE in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. The main outcome parameter for efficiency was clinical improvement after completion of treatment with PE/IA. Symptoms were assessed before the first and after the last IA/PE. In total, all patients receive 5 treatments. As patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.
656 studies on the registry are indexed under Autoimmune Diseases; 276 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 428 interventional studies indexed under Autoimmune Diseases.
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Exclusion Criteria:
patients were treated with plasma exchange
Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
patients were treated with immunadsorption
Other: Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.
Also known as: IA treatment: using single-use tryptophane adsorber TR 350 in combination with the OP-0,5W plasma separator (Asahi Kasei Medical, Tokyo, Japan) and the tubing system PA-420, PE treatment: using Plasmaflow OP 0,5W (L) and the tubing system AV-120 and FS-250
Change in descriptive characterization of Symptoms
Patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.
Time frame: After 7 days. Symptoms were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).]
Change in the "Expanded Disability Status Scale" (EDSS)
In the subgroup of MS patients, disability was evaluated by EDSS. The Expanded Disability Status Scale is a scale system for the systematic recording (assessment) of disability in neurological patients suffering from multiple sclerosis. The scale is used to classify the severity of disability by symptoms, ranging from 0 (no symptoms) to a maximum of grade 10 (death from MS).
Time frame: After 7 days. EDSS were assessed at baseline before the first intervention (day 1) and immediately after the last intervention (day 7).
Change in concentration of Immunglobulins
Measurement of IgE, IgM, IgG levels and IgG subclasses.
Time frame: After 7 days. Immunglobulins were measured before and after the first intervention (day 1) and immediately before after the last intervention (day 7).
Change in concentration of human cytokines
Measurement of IL-12, IL-17, IL-18, CSF-1, IL-34, IL-6, TNF-alpha and IL-28.
Time frame: After 7 days. Cytokines were measured before and after the first intervention (day 1) and immediately before and after the last intervention (day 7).
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University Medical Center Mainz