NCT05025956

Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan

The Use of Senolytic Agent to Improve the Benefit of Platelet-Rich Plasma and Losartan for Treatment of Femoroacetabular Impingement and Labral Tear: A Pilot Study

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Steadman Philippon Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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 for treatment of femoroacetabular impingement and labral tear. We believe that giving Fisetin, a senolytic agent, will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP), known to exist in PRP. The main objectives of this study are to determine if pre- and post-operative administration of a senolytic agent will improve the beneficial effects of PRP when used in conjunction with surgical treatment of FAI and/or labral tear, to determine whether pre- and postoperative administration of Fisetin is associated with adverse events, and to determine if pre- and post-operative administration of Fisetin leads to a decrease in systemic senescence, serum SASP, and fibrotic markers. Patients suffering from femoroacetabular impingement and labral tear, who are planning to undergo hip arthroscopy combined with standard of care intra-operative PRP injection and post-operative losartan administration will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC).

Detailed description

This is a pilot, prospective, randomized, double-blind, placebo control clinical trial is proposed to evaluate the safety and efficacy of a senolytic agent (Fisetin) to improve the benefits of standard of care platelet rich plasma (PRP) injection and antifibrotic medication (Losartan) in patients undergoing hip arthroscopy for treatment of femoroacetabular impingement (FAI) and/or labral tear (LT).

Conditions

• Femoroacetabular Impingement

Interventions

Type	Name	Description
DRUG	Fisetin	Oral Fisetin 20 mg/kg taken for 8 days total.
DRUG	Placebo	Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total.

Timeline

• Start date: 2021-10-24
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2021-08-30
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study