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Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

24 Participants Needed

Immune Profiling via Thoracic Duct Cannulation for Multiple Sclerosis

Overseen ByMargaux Giardino

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Interferons, Glatiramer acetate

Must not be taking: Systemic glucocorticoids

Disqualifiers: Primary progressive MS, Neuromyelitis optica, Active chronic immune disease, Active infections, Cardiovascular disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have used systemic glucocorticoids in the past 4 weeks and should have a treatment history limited to Interferons or glatiramer acetate, or be untreated. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Thoracic Duct Cannulation for Multiple Sclerosis?

The research suggests that drainage of the thoracic duct may help control the immune system in patients with multiple sclerosis by addressing immune imbalances that are resistant to other treatments. This approach is based on studies showing changes in immune cells in the blood and cerebrospinal fluid, which are important in managing the disease.¹ ² ³ ⁴ ⁵

How does the treatment involving thoracic duct cannulation differ from other treatments for multiple sclerosis?

This treatment is unique because it involves draining the thoracic duct, which is part of the lymphatic system, to help control the immune system's balance in patients with progressive multiple sclerosis. This approach is different from standard treatments as it targets the immune system's homeostasis directly, rather than using drugs to suppress or stimulate the immune response.¹ ² ³ ⁶ ⁷

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.

Research Team

Amit Bar-Or, MD

Principal Investigator

University of Pennsylvania

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

My MS symptoms have not worsened in the last month.

I haven't taken any steroid medications in the last 4 weeks.

Written informed consent must be obtained before any assessment is performed.

See 7 more

Exclusion Criteria

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

I have been diagnosed with neuromyelitis optica.

Your body has too few infection-fighting white blood cells.

See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with MS receive Ofatumumab treatment and undergo lymphatic fluid collection via catheterization

3 weeks

Multiple time-point sampling

Follow-up

Participants are monitored for safety and immune cell profile changes after treatment

2 years

Treatment Details

Interventions

Thoracic Duct Cannulation

Trial Overview 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.

Participant Groups

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)