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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
B Cells
Safety and Tolerability
Secondary outcome measures
Immune cell profiles (MS and healthy controls)
Immune cell profiles (ofatumumab)
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)
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,036 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
887 Patients Enrolled for Multiple Sclerosis
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,326 Total Patients Enrolled
100 Trials studying Multiple Sclerosis
52,103 Patients Enrolled for Multiple Sclerosis
Novartis Institutes for BioMedical ResearchOTHER
4 Previous Clinical Trials
653 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic immune system disease other than MS, or an immunodeficiency syndrome.My MS symptoms have not worsened in the last month.I have been diagnosed with neuromyelitis optica.I am between 18 and 40 years old.I haven't taken any steroid medications in the last 4 weeks.Your body has too few infection-fighting white blood cells.My condition has been diagnosed for over 10 years.Your hemoglobin level is less than 10.0 grams per deciliter.I have a history of diabetes.I have not had any live vaccines in the last 2 months.I haven't had non-live vaccines in the last 2 weeks.You have a positive test for hepatitis B or C indicating a current or past infection.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.Your blood clotting time (PT or INR) is more than 1.5 times higher than the normal range.I can have multiple MRIs for my MS condition.My MS diagnosis follows the 2017 McDonald criteria.I am at risk for syphilis or tuberculosis reactivation.I do not have any active infections or AIDS.I haven't taken any experimental drugs recently.My MS disability score is between 0 and 4.You can safely have multiple MRI scans.I need more information to rewrite this criterion in simpler language. Can you provide additional details about the criteria for participants with MS?You have a low platelet count.I have been diagnosed with primary progressive multiple sclerosis.I have symptoms or a confirmed diagnosis of PML.I have MS and have only been treated with Interferons or glatiramer, or not treated at all.
Research Study Groups:
This trial has the following groups:- Group 1: 'In-and-out' catheterization
- Group 2: "Indwelling" catheterization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for potential participants to enroll in this experiment?
"To be accepted for the trial, applicants must meet two criteria: they need to have multiple sclerosis and fall within 18 - 40 years of age. This clinical assessment is looking to recruit a total of 24 participants."
Answered by AI
Is this review amenable to those aged 25 and older?
"The eligibility requirements for this medical trial dictates that prospective participants must be no younger than 18 and not older than 40."
Answered by AI
Is this scientific research looking for new participants?
"According to clinicaltrials.gov, no new participants are being sought for this study at the moment; however it was first listed on April 19th 2022 and last modified on August 25th 2022. Currently, 1397 other studies across the globe are actively seeking enrolment from patients."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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