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Senolytic
Fisetin for Meniscus Tears
Phase 2 & 3
Waitlist Available
Led By Austin Stone, MD, PhD
Research Sponsored by Austin V Stone
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are ambulatory as defined by ability to complete functional performance testing
Medial, lateral or combined meniscus tear treated with surgical repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year
Awards & highlights
Study Summary
This trial will test a new intervention for meniscus injury that includes a pill and a real-time feedback program to help restore joint function.
Who is the study for?
This trial is for men and women aged 18-45 who have had a surgical repair for a meniscus tear in the knee. Participants must be able to walk and follow study procedures, with stable medication use for at least 2 months before the trial. Excluded are those unable to consent or take oral meds, recent knee surgery patients, certain drug users (e.g., Warfarin), pregnant/nursing women, and individuals with severe liver/renal disease or joint diseases.Check my eligibility
What is being tested?
The clinical trial tests an intervention combining fisetin—a senolytic agent thought to help with cellular aging—and biofeedback after meniscal repair surgery. The goal is to improve joint loading and activity return post-surgery. Participants will either receive fisetin or a placebo capsule without knowing which one they're taking.See study design
What are the potential side effects?
While specific side effects of fisetin aren't detailed here, common ones may include digestive discomfort, allergic reactions, or headaches based on similar compounds' profiles. Biofeedback typically has no side effects but can cause frustration if progress isn't perceived.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk and complete physical tests.
Select...
I had surgery to repair a tear in my knee's meniscus.
Select...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in International Knee Documentation Committee (IKDC) Score between baseline and 1 year
Secondary outcome measures
Change in MRI T1rho between baseline and 1 year
Side effects data
From 2022 Phase 2 trial • 55 Patients • NCT047716117%
Rash
7%
hyperhidrosis
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
3%
hypertension
3%
tachycardia
3%
amnesia
3%
asthma with exacerbation
3%
Anosmia
3%
migraine
3%
conjunctivitis
3%
rhinitis
3%
flu like symptoms
3%
Otitis media
3%
vertigo
3%
edema, hand, bilateral
3%
bacterial vaginosis
3%
ear pain, left
3%
cough
3%
Upper Respiratory Infection
3%
Epistaxis
3%
flatulence
3%
shortness of breath
3%
arthoplasty
3%
ageusia
3%
change in smell
3%
vomiting
3%
fatigue
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
watering eyes (epiphora)
3%
Systolic murmur
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FisetinExperimental Treatment1 Intervention
Subjects assigned to the experimental group will take approximately 20 mg/kg/day of fisetin for 2 consecutive days, followed by a 28-day senescence washout period, and then another 2-day administration. Fisetin treatment begins at 8 weeks after surgery.
Group II: PlaceboPlacebo Group1 Intervention
Subjects assigned to the experimental group will take approximately 20 mg/kg/day of placebo (corn starch) for 2 consecutive days, followed by a 28-day washout period, and then another 2-day administration. Placebo treatment begins at 8 weeks after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Austin V StoneLead Sponsor
4 Previous Clinical Trials
36 Total Patients Enrolled
Austin Stone, MD, PhDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received joint injections.I am not taking medications that strongly affect certain liver enzymes.I am currently on Warfarin or similar blood thinners.I have not had specific treatments in the mentioned time frame.I have not had surgery on my knee in the last 6 months.I am currently taking Losartan.I am unable to give consent for medical procedures by myself.I cannot take medicine by mouth.I am not taking cyclosporine, tacrolimus, repaglinide, or bosentan, or can stop them for 2 days.I can walk and complete physical tests.I am a male willing to use contraception or abstain from sex during and for 2 weeks after the study.My condition matches one of the specified disease statuses.I have an active autoimmune disease affecting my muscles or joints.I had surgery to repair a tear in my knee's meniscus.I had knee surgery within the last 2 years.I have not taken senolytic agents like Fisetin or Dasatinib in the last 6 months, or I am willing to stop taking them for the study.I have severe knee arthritis, a knee injury, or had knee surgery within the last year.My current medications have been the same for the last 2 months.I do not have moderate to severe depression (PHQ-9 score ≤ 10).I have taken opioid painkillers in the last 8 weeks.I am not taking, or willing to stop taking, strong chemotherapy drugs for the study.My kidney function is reduced, with an eGFR below 60.I have been diagnosed with a specific joint disease other than arthritis.My liver is functioning well, with bilirubin levels not twice the normal limit.I do not have severe cartilage damage in my knee.I am currently taking or have recently stopped taking certain medications.I am between 18 and 45 years old.I am not pregnant, nursing, or planning to become pregnant during the study.I have had knee replacement surgery, but it was over 6 months ago and my knee feels fine.I have taken glucocorticoids in the last 2 months.I have diabetes with HbA1c over 6.5% or I'm on diabetes medication.I haven't had steroid, hyaluronic acid, or biologic injections in my knee in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Fisetin
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Are elderly individuals able to participate in this research?
"This specific trial requires that potential participants between the ages of 18 to 45. On clinicaltrials.gov, there is 1 study for those under 18 and 10 trials recruiting patients over the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
UK Healthcare at Turfland
What portion of applicants met pre-screening criteria?
Did not meet criteria
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