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Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation

Analysis of Lymphatic Fluid From the Thoracic Duct of Healthy People and People With Multiple Sclerosis (MS) Before and After Ofatumumab Treatment

NCT05162638•University of Pennsylvania

View on ClinicalTrials.gov

Summary

In this study, lymph fluid will be collected by cannulation of the thoracic duct, a minimally invasive procedure performed by interventional radiologists. Single time point and serial collection through an indwelling cannula will allow for comparisons between immune cells in the periphery and deep lymphatic system in MS and healthy controls and in MS, changes in responses to a FDA approved therapy ofatumumab.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants eligible for inclusion in this study must meet all of the following criteria:
•1. Written informed consent must be obtained before any assessment is performed.
•2. Adult participants aged 18 to 40 years (inclusive) at Screening.
•3. Participants must be able to understand English and be able to review and comprehend the informed consent form independently or with the help of research staff
•4. No use of systemic glucocorticoids in the past 4 weeks
•For participants with MS following additional criteria need to be met:
•1. Diagnosis of MS according to the 2017 Revised McDonald criteria.
•2. Ability to undergo several MRIs
•3. Disability status at Screening with an EDSS score of 0 to 4 (inclusive)
•4. MS treatment history restricted to Interferons and/glatiramer acetate treatment only or untreated to date
+1 more criteria

Exclusion Criteria

•1\. Participants suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator.
•2\. Participants with primary progressive MS (Polman C et al., 2011) 3. Participants meeting criteria for neuromyelitis optica (Wingerchuck D et al., 2015) 4. Participants with disease duration of more than 10 years 5. Participants who are pregnant or nursing (lactating) 6. Participants with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency) 7. Participants with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS) 8. Participants with neurological symptoms consistent with PML or confirmed PML 9. Participants at risk of developing or having reactivation of syphilis or tuberculosis 10. History of cardiovascular disease or uncontrolled hypertension 11. History of diabetes mellitus 12. History of cancer (other than localized skin cancer) in the previous 5 years 13. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to first study drug administration 14. Immunization with non-live vaccines within 2 weeks of the study procedure 15. Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) B and C indicating acute or chronic infection:
•1. HBs Ag and/or anti-HBc IgM and/or HB virus deoxyribonucleic acid (DNA)
•2. anti-HBs negative and Anti-HBc positive
•3. anti-HC IgG (if positive IgG, HCV-RNA PCR will be performed and if negative, participant can be enrolled) 16. Use of other investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer 17. Absolute neutrophil count (ANC) \<750/mm3; 18. Hemoglobin \<10.0 g/dL 19. Platelet count \<100,000/mm3 20. Prothrombin time (PT) or international normalized ration (INR) \>1.5 x ULN

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 19, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

Multiple SclerosisHealthy

Interventions

thoracic duct cannulation

PROCEDURE

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RECRUITING

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Healthy Volunteer

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RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation

Inclusion Criteria

Exclusion Criteria

A New Portable Device for Non-invasive Ventilatory Support

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Intermittent Hypoxia in Persons With Multiple Sclerosis

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