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Fisetin for Femoroacetabular Impingement
Phase 1 & 2
Recruiting
Led By Johnny L Huard, PhD
Research Sponsored by Steadman Philippon Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to undergo hip arthroscopy to treat FAI and/or a hip labral tear
Between 18 and 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Awards & highlights
Study Summary
This trial is designed to see if giving Fisetin to patients with femoroacetabular impingement and labral tear will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP).
Who is the study for?
Adults aged 18-80 with femoroacetabular impingement (FAI) or a hip labral tear, who can consent and follow study procedures. They must be scheduled for hip arthroscopy but cannot have had previous significant hip surgeries, systemic autoimmune diseases, uncontrolled diabetes, recent use of certain drugs like warfarin or senolytic agents, or conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing whether Fisetin (a drug thought to remove aging cells) can enhance the effects of Platelet-Rich Plasma and losartan in treating FAI and labral tears when used before and after surgery. A placebo group will serve as a comparison to measure Fisetin's effectiveness.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Fisetin or Losartan ingredients, interactions with other medications not allowed in the trial, and general risks associated with taking new medications which will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for hip surgery to address FAI or a hip labral tear.
Select...
I am between 18 and 80 years old.
Select...
I have been diagnosed with FAI or a hip labral tear.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy
Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood
Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS)
+6 moreSide 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: Fisetin group (investigational group)Experimental Treatment1 Intervention
20mg/kg of Fisetin per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery.
(The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day)
Group II: Placebo group (control group)Placebo Group1 Intervention
20mg/kg of Placebo per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery.
(The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~170
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
United States Department of DefenseFED
861 Previous Clinical Trials
227,126 Total Patients Enrolled
Steadman Philippon Research InstituteLead Sponsor
9 Previous Clinical Trials
547 Total Patients Enrolled
Johnny L Huard, PhDPrincipal InvestigatorSteadman Philippon Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with fibromyalgia.I am scheduled for hip surgery to address FAI or a hip labral tear.My hip condition is moderately to severely degenerated.I have taken steroids within the last month.I cannot or do not want to receive a PRP injection.I have or might have an autoimmune disease or a history of inflammatory arthritis.I have not taken insulin-affecting medications in the last week.I have had AVN, Perthes disease, or SCFE in the past.I am between 18 and 80 years old.I have no other joint diseases that could affect the study.I have not taken any drugs that target aging cells recently.I have had surgery for hip dysplasia.I have had pigmented villonodular synovitis or synovial chondromatosis.I have had or am planning to have surgery or treatment on my hip.I am on medication that cannot be stopped for Fisetin treatment.I have been diagnosed with FAI or a hip labral tear.I am currently on medication that affects blood clotting.I can make my own medical decisions and will follow the study's requirements.I cannot take medicine by mouth.I am not pregnant, nursing, planning to become pregnant, and willing to use contraception.I am a man and will use contraception if having sex with a woman who can have children.I am not allergic to Losartan or Fisetin, and I'm not on conflicting medications.I am currently on medication for seizures, thyroid issues, or bone health.I have been diagnosed with FAI or a hip labral tear.I can make my own medical decisions and agree to follow the study's requirements.I am scheduled for hip surgery to fix FAI or a torn labrum.
Research Study Groups:
This trial has the following groups:- Group 1: Fisetin group (investigational group)
- Group 2: Placebo group (control group)
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.
To what extent is participation in this research project widespread?
"Affirmative. Records hosted on clinicaltrials.gov affirms that the medical trial, first posted October 24th 2021, is still looking for participants. A total of 100 patients need to be recruited from 1 healthcare facility."
Answered by AI
Have prior experiments involved Fisetin explored potential outcomes?
"Currently, there are 6 clinical trials researching the effects of Fisetin with none in Phase 3. While Memphis is by far the most frequent location for these studies, they can be found at other sites as well."
Answered by AI
Am I eligible to partake in this experiment?
"This clinical trial requires 100 participants with femoracetabular impingement that fit within the age range of 18 and 80. To be eligible, you must meet these conditions: You are aged between 18 and 80, You have a scheduled hip arthroscopy to treat FAI or a labral tear in your hip."
Answered by AI
Are individuals aged 45 years or below eligible to participate in the research?
"This clinical trial is open to persons aged between 18 and 80. Furthermore, there are 4 trials available for minors and 11 separate studies targeting individuals over 65 years old."
Answered by AI
Is enrollment for this trial currently accessible to potential participants?
"Affirmative. Information from clinicaltrials.gov indicates that this medical study is currently enrolling volunteers, with the original posting date of October 24th 2021 and most recent amendment on October 6th 2022. The trial requires 100 patients at a single site to participate in the experiment."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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