What is the mechanism of action of this treatment?

Common treatments for Femoroacetabular Impingement (FAI) include the use of senolytic agents like Fisetin, which eliminate senescent cells and reduce the senescence-associated secretory phenotype (SASP). This reduction in senescent cells and SASP can decrease inflammation and improve the healing environment. Additionally, treatments like Platelet-Rich Plasma (PRP) promote tissue repair and regeneration, while losartan helps reduce fibrosis and improve tissue remodeling. These combined approaches aim to alleviate symptoms, enhance joint function, and slow the progression of joint damage in FAI patients.

What side effects are associated with this type of intervention?

Common treatments for Femoroacetabular Impingement (FAI) include surgical interventions, Platelet-Rich Plasma (PRP) injections, and medications like losartan. Surgical treatments can lead to complications such as infection, blood clots, and nerve damage. PRP injections are generally safe but can cause pain at the injection site, infection, and allergic reactions. Losartan can cause dizziness, fatigue, and elevated potassium levels. Fisetin, a senolytic agent, is still under investigation, but potential side effects could include gastrointestinal discomfort and allergic reactions.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Femoroacetabular Impingement (FAI) in the provided context. However, the trial involving Fisetin, a senolytic agent, is being studied for its potential to improve the benefits of Platelet-Rich Plasma (PRP) and losartan in treating FAI. Senolytic agents like Fisetin work by eliminating senescent cells and reducing the senescence-associated secretory phenotype (SASP), which may enhance the healing process and reduce inflammation. While this specific combination is under investigation, PRP and anti-inflammatory treatments like losartan are commonly used in managing FAI.

What other types of research exist?

Promising alternatives to Fisetin for Femoroacetabular Impingement patients include: 1) Sorbinil, an aldose reductase inhibitor, which has shown improvement in joint mobility and strength in diabetic patients with limited joint mobility. 2) Gold-coated superparamagnetic iron oxide nanoparticles (AuSPION), which have demonstrated significant clinical improvements in reducing joint inflammation in arthritis models. These alternatives may offer novel therapeutic benefits for FAI patients.

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Fisetin for Femoroacetabular Impingement

Phase 1 & 2

Waitlist Available

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

Must not have

Current diagnosis of fibromyalgia

Tönnis Grade 2-3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op

Summary

This trial is testing if Fisetin, which removes old, damaged cells, can help patients with hip issues heal better after surgery by reducing inflammation.

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.

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.

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 below

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

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I am between 18 and 80 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with fibromyalgia.

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My hip condition is moderately to severely degenerated.

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I cannot or do not want to receive a PRP injection.

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I have or might have an autoimmune disease or a history of inflammatory arthritis.

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I have not taken insulin-affecting medications in the last week.

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I have had AVN, Perthes disease, or SCFE in the past.

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I have not taken any drugs that target aging cells recently.

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I have had surgery for hip dysplasia.

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I have had pigmented villonodular synovitis or synovial chondromatosis.

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I have had or am planning to have surgery or treatment on my hip.

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I am currently on medication that affects blood clotting.

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I cannot take medicine by mouth.

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I am not pregnant, nursing, planning to become pregnant, and willing to use contraception.

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I am a man and will use contraception if having sex with a woman who can have children.

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I am not allergic to Losartan or Fisetin, and I'm not on conflicting medications.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events

Secondary study objectives

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 more

Side effects data

From 2023 Phase 1 & 2 trial • 75 Patients • NCT04210986

38%

Arthralgia

15%

Pain in Extremity

12%

Lab Findings

12%

Nausea

Fatigue

Back Pain

Headache

Muscle Cramp

Flatulence

Dry Mouth

Rash Maculo-Papular

Covid 19

Bladder Perforation

Neoplasms

Rotator Cuff Injury

100%

80%

60%

40%

20%

Study treatment Arm

Fisetin

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

~250

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Femoroacetabular Impingement (FAI) include the use of senolytic agents like Fisetin, which eliminate senescent cells and reduce the senescence-associated secretory phenotype (SASP). This reduction in senescent cells and SASP can decrease inflammation and improve the healing environment. Additionally, treatments like Platelet-Rich Plasma (PRP) promote tissue repair and regeneration, while losartan helps reduce fibrosis and improve tissue remodeling. These combined approaches aim to alleviate symptoms, enhance joint function, and slow the progression of joint damage in FAI patients.

Tolmetin in osteoarthrosis of the hip and knee: double-blind crossover trials.Aldose reductase inhibition and the diabetic syndrome of limited joint mobility: implications for altered collagen hydration.The effect of an aldose reductase inhibiting agent on limited joint mobility in diabetic patients.