Immune Profiling via Thoracic Duct Cannulation for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

Overseen ByAmit Bar-Or, MD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults aged 18-40, both healthy and those with Multiple Sclerosis (MS) who are neurologically stable. MS patients must have been diagnosed per the McDonald criteria, have an EDSS score of 0-4, and be untreated or only on specific MS medications. Participants must understand English and not have used steroids recently.

Inclusion Criteria

I am between 18 and 40 years old.

My MS diagnosis follows the 2017 McDonald criteria.

My MS disability score is between 0 and 4.

I have MS and have only been treated with Interferons or glatiramer, or not treated at all.

Exclusion Criteria

I have a chronic immune system disease other than MS, or an immunodeficiency syndrome.

I have been diagnosed with neuromyelitis optica.

My condition has been diagnosed for over 10 years.

I have a history of diabetes.

I have not had any cancer, except for skin cancer, in the last 5 years.

I have a history of heart disease or high blood pressure that is not well-controlled.

I do not have any active infections or AIDS.

I have been diagnosed with primary progressive multiple sclerosis.

I have symptoms or a confirmed diagnosis of PML.

Participant Groups

The study involves collecting lymph fluid through thoracic duct cannulation to compare immune cells in MS patients versus healthy controls. It also examines changes in response to the FDA-approved therapy ofatumumab in MS patients.

2Treatment groups

Experimental Treatment

Group I: 'In-and-out' catheterizationExperimental Treatment1 Intervention

Safety and immune-cell profile of lymphatic fluid in MS patients with a single time-point sampling of lymphatic fluids and peripheral blood compared to healthy controls. Two healthy controls and six patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to the 'In-and-out' catheter procedure. MS participants can also consent to OMB treatment with 2-year follow-up.

Group II: "Indwelling" catheterizationExperimental Treatment1 Intervention

immune-biology in people with MS before and during/after OMB treatment within thoracic duct and peripheral blood via indwelling catheter and multiple time-point sampling compared to healthy controls (without drug treatment). Twelve patients with early MS (never treated or at least 90 days after discontinued treatment with glatiramer acetate or interferons), who consent to treatment with OMB and to the indwelling catheter procedure with serial sampling and up to four healthy controls (no drug treatment)