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Immune Profiling via Thoracic Duct Cannulation for Multiple Sclerosis

N/A

Waitlist Available

Led By Amit Bar-Or, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants aged 18 to 40 years (inclusive) at Screening.

For participants with MS: Diagnosis of MS according to the 2017 Revised McDonald criteria.

Must not have

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)

Participants meeting criteria for neuromyelitis optica (Wingerchuck D et al., 2015)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will collect lymph fluid from the thoracic duct to compare immune cells in MS patients and healthy controls, as well as changes in responses to ofatumumab in MS patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, thoracic duct cannulation is minimally invasive but may include risks such as infection at the insertion site, bleeding, or discomfort related to the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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My MS diagnosis follows the 2017 McDonald criteria.

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My MS disability score is between 0 and 4.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with neuromyelitis optica.

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My condition has been diagnosed for over 10 years.

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I have a history of diabetes.

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

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

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I do not have any active infections or AIDS.

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I have been diagnosed with primary progressive multiple sclerosis.

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I have symptoms or a confirmed diagnosis of PML.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

B Cells

Safety and Tolerability

Secondary study objectives

Immune cell profiles (MS and healthy controls)

Immune cell profiles (ofatumumab)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 13Eligibility criteria met