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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05162638
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • thoracic duct cannulation — PROCEDURE
    Contrast is injected into lymph nodes until lymphatics visualized at about level of L3 lumbar spine. After target lymphatic vessel is identified, needle is passed transabdominally into the vessel. Guidewire is advanced through the needle into the lymph vessel \& advanced into thoracic duct. Microcatheter is then advanced into thoracic duct over the wire. IN \& OUT-up to 100mL collected via catheter over 30-min at 2 levels within thoracic duct, then catheter removed. INDWELLING-As described above, then guidewire placed through original catheter \& advanced into subclavian vein. Vascular sheath is placed into vein in the upper arm under ultrasound/fluoroscopy guidance. Wire in the subclavian vein then snared through venous access sheath \& pulled out. Catheter then threaded \& advanced over the wire until tip is in thoracic duct. Catheter from thoracic duct removed, leaving catheter extending from arm into thoracic duct. Catheter left in place up to 21 days for sampling.

Study Details

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.

Key Dates

Start date
Apr 19, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: 'In-and-out' catheterization
    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.
  • Other: "Indwelling" catheterization
    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)

Primary Outcome Measure

Safety and Tolerability [ Time Frame: up to 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Pennsylvania· Philadelphia, PA

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