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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Safety and Tolerability
Quantified as percent of the study population experiencing serious adverse event from in-and-out catherization procedure and from "indwelling" catheterization procedure
Time frame: up to 21 days
B Cells
Change in proportion of flow cytometry defined naïve (CD27-) and memory (CD27+) B cells in thoracic duct of patients with MS prior to and following anti-CD20 therapy with Ofatumumab
Time frame: up to 21 days
Immune cell profiles (MS and healthy controls)
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood between MS and healthy controls
Time frame: up to 21 days
Immune cell profiles (ofatumumab)
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood of MS patients prior to and following treatment with the anti-CD20 Ofatumumab
Time frame: up to 21 days
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