Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial
United States75 participantsStarted 2020-01-06
Plain-language summary
Phase I/II randomized, double-blind, placebo-controlled clinical trial to test the safety and efficacy of Fisetin for treating mild to moderate osteoarthritis
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Are male or female, ages 40-80;
. Are willing to comply with all study related procedures and assessments;
. Are ambulatory as defined by ability to complete functional performance testing;
. Radiographic evidence of Kellgren-Lawrence grade II-IV osteoarthritis in one or both knees;
. Scores 4-10 on the Numerical Rating Scale (NRS) for pain;
. Stable dose of screening/baseline medications for at least 2 months prior to the anticipated date of study drug dosing.
Exclusion criteria
. Females who are nursing, pregnant or planning to become pregnant during the duration of study drug dosing;
. Males who do not wish to abstain from sex or use contraceptive protection during study drug dosing and for 2 weeks after the last dose;
. Subjects who do not have the capacity to consent themselves;
. Subjects who are unable to tolerate oral medication;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing One or More Treatment-Emergent Adverse Event
Timeframe: Duration of study, an average of 12 months
. Subjects having previously undergone any of the following treatments in the stated time window.
. Subjects with any of the following drug/medication statuses:
. Subjects with any of the following disease statuses:
. Subjects unable to safely practically undergo an MRI (BMI \> 40 kg/m2) or size exceeding limits of MRI equipment, implanted metal in study knee near joint surface, incompatible implant/device, severe claustrophobia;