Fisetin for Femoroacetabular Impingement

Overseen By Luz Thede, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Steadman Philippon Research Institute

Must be taking: Losartan, PRP

Must not be taking: Warfarin, Metformin, Senolytics, Chemotherapy

Disqualifiers: Hip surgeries, Autoimmune diseases, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Fisetin, a substance that clears old and damaged cells, can enhance the effects of platelet-rich plasma (PRP) and losartan in treating hip conditions like femoroacetabular impingement and labral tears. Researchers aim to determine if taking Fisetin before and after hip surgery improves recovery and reduces harmful cells in the body. Individuals diagnosed with these hip issues and scheduled for hip arthroscopy with PRP and losartan treatment may be suitable for this study. As a Phase 1, Phase 2 trial, the study seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications before and during the study. Specifically, you must stop taking cyclosporine, tacrolimus, repaglinide, and bosentan at least 2 days before and during Fisetin administration. Additionally, you cannot take medications that affect insulin activity, certain senolytic agents, or drugs that induce cellular senescence.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fisetin, a compound under study for its potential to target aging cells, might help manage several chronic diseases. Studies have explored how fisetin could remove these old cells, possibly improving health in these conditions. Although fisetin is still being tested, early results suggest it could be safe for humans.

In clinical trials, the current stage of research for fisetin indicates it is safe enough for human testing, with serious side effects not expected to be common. However, as research continues, new information may emerge.

For those considering joining a trial involving fisetin, it's important to know that studies so far suggest it seems safe. However, like any study, there might be risks. Always discuss possible side effects with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for femoroacetabular impingement?

Fisetin is unique because it's a natural compound found in fruits and vegetables, and researchers believe it could help reduce inflammation and improve recovery in femoroacetabular impingement (FAI). Unlike standard treatments, which often involve pain management and physical therapy, Fisetin might offer additional benefits by targeting cellular senescence, a process linked to aging and inflammation. Researchers are excited about Fisetin because it's not only potentially effective but also has a good safety profile, making it an attractive option for enhancing recovery in FAI patients.

What evidence suggests that Fisetin might be an effective treatment for femoroacetabular impingement?

Research has shown that fisetin, a compound capable of clearing out old cells, may help reduce inflammation. These old cells, which have stopped dividing, can cause inflammation if they accumulate. By removing them, fisetin might enhance treatments like Platelet-Rich Plasma (PRP) and losartan for hip pain caused by femoroacetabular impingement. Studies suggest that fisetin could lower inflammation and improve healing. This trial will investigate fisetin as a potential way to enhance existing hip treatments. Although more research is needed, early findings are promising. ^{1 5 6 7 8}

Who Is on the Research Team?

Johnny L Huard, PhD

Principal Investigator

Steadman Philippon Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for hip surgery to address FAI or a hip labral tear.

I have been diagnosed with FAI or a hip labral tear.

I can make my own medical decisions and will follow the study's requirements.

Exclusion Criteria

Joint space less than or equal to 2mm

I have been diagnosed with fibromyalgia.

History of drug and/or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive 20mg/kg of Fisetin or placebo per day for 2 days prior to surgery

2 days

Surgery and Immediate Post-operative Care

Participants undergo hip arthroscopy with intra-operative PRP injection and post-operative losartan administration

1 week

Post-operative Treatment

Participants receive 20mg/kg of Fisetin or placebo on days 33, 34, 63, 64, 93, and 94 post-surgery

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Fisetin
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Fisetin group (investigational group) Experimental Treatment 1 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 Group 1 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)

Who Is Running the Clinical Trial?

Steadman Philippon Research Institute

Lead Sponsor

Trials

11

Recruited

700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05025956

Study Details | NCT05025956 | Senolytic Agent Improve ... The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0047637424000952

Fisetin as a senotherapeutic agent: Evidence and ... Our review of available data suggests that targeting senescent cells with fisetin offers a promising strategy for managing multiple chronic diseases.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6670054/

SHORT-TERM OUTCOMES OF CONSERVATIVE ... Results showed that conservative interventions for short-term periods are effective in reducing pain and improving function for femoroacetabular impingement.

4. researchgate.net researchgate.net/profile/Patrick-Owen-2/publication/351273338_Six_Meta-analyses_on_Treatments_for_Femoroacetabular_Impingement_Syndrome_in_a_Year_and_Readers_Are_None_the_Wiser_Methods_Advice_for_Researchers_Planning_Meta-analysis_of_Data_From_Fewer_Than_5_Trial/links/61d79b12da5d105e5522c334/Six-Meta-analyses-on-Treatments-for-Femoroacetabular-Impingement-Syndrome-in-a-Year-and-Readers-Are-None-the-Wiser-Methods-Advice-for-Researchers-Planning-Meta-analysis-of-Data-From-Fewer-Than-5-Trial.pdf

Six-Meta-analyses-on-Treatments-for-Femoroacetabular- ... analysis of data from fewer than five trials. 3. 4. Tobias Saueressig ... Femoroacetabular Impingement (FAI) syndrome is characterised by hip pain ...

5. hca.wa.gov hca.wa.gov/assets/program/FAI-signals-search-update-2023.pdf

Safety and Efficacy of Femoroacetabular Impingement ... However, PT did result in improved outcomes and did not appear to compromise the surgical. Page 17. WA Health Technology Assessment – Signals ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05025956?term=FISETIN&rank=10

Senolytic Agent Improve the Benefit of Platelet-Rich ... This is a pilot, prospective, randomized, double-blind, placebo control clinical trial is proposed to evaluate the safety and efficacy of a senolytic agent ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309009/

Hip muscle changes in femoroacetabular impingement FAI patients exhibited significantly reduced hip flexion (− 0.338 Nm/kg) and extension (− 0.379 Nm/kg) strength versus controls, with ...

8. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/37513-an-updated-review-of-femoroacetabular-impingement-syndrome

An Updated Review of Femoroacetabular Impingement ... FAI often leads to labral, cartilaginous, and tissue damage that predispose this patient population to early osteoarthritis (OA).1,2 FAI was ...