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

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 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+