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Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Objective: To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response. The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients aged 18-65 years who are able to give informed consent and have: i) ME/CFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score \< 60

• Presence of autoantibodies (adrenergic or antineuronal antibodies)

• Undergoing IA with the TheraSorb® column over 5 days

• Written informed consent provided by the patient

• Health insurance coverage

Locations
Other Locations
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Contact Information
Primary
Elisa A Stein, Dr.
elisa.stein@charite.de
+49 450 624354
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Collaborators: German Federal Ministry of Research, Technology, and Space (BMFTR), Weidenhammer-Zöbele Foundation
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov