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

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Femoroacetabular Impingement

In brief

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).

Key facts

Study ID

NCT05025956

Run by

Steadman Philippon Research Institute

People needed

68

Starts

2021-10-24

Expected to finish

2024-10-31

Last updated by the study team

2024-04-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments
• Between 18 and 80 years of age
• Have been diagnosed with femoroacetabular impingement (FAI) and/or a hip labral tear
• You are scheduled to undergo hip arthroscopy to treat FAI and /or a hip labral tear

You may not qualify if…

• Previous or Planned Hip Surgeries, Procedures and/or Treatments:
• Planned surgery on either the contralateral or target hip at any time during the Study period including dosing and follow-up
• Require microfracture on the target hip as part of the planned arthroscopy
• Within 6 months of signing informed consent, has undergone regenerative hip joint procedures on the target hip including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation
• Have had previous surgery (including microfracture) or diagnostic arthroscopy on the target hip
• Joint space less than ≤2mm
• Tönnis Grade 2-3
• Have a history of pigmented villonodular synovitis (joint disease characterized by inflammation and overgrowth of the synovial lining of the hip joint)
• Have a history of synovial chondromatosis (noncancerous tumor that develops in the synovial lining of the hip joint);
• Have a history of hip dysplasia requiring PAO
• History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
• Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis
• Current diagnosis of fibromyalgia based on ACR criteria
• Are unable to or are unwilling to receive a PRP injection as part of your surgery
• Inadequate amount of PRP collected to serve the needs of the patient, and/or ProofPoint Biologics
• Within 2 years of signing informed consent, history of active blood clotting disorders requiring preventative treatment, or active malignancy of any type or history of a malignancy (with the exception of subjects with a history of treated basal or squamous cell carcinoma)
• Baseline HbA1C greater than 6.5, uncontrolled diabetes mellitus, and/or medication management has not been stable in the previous 2 months
• Current or prior history of other joint diseases that may (in the opinion of the Principal Clinical Investigator or his/her designee) confound study data or increase Subject risk. These may include including but not limited to joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and/or radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler syndrome, joint infection, hemochromatosis, or neuropathic arthropathy of any cause
• Any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the Study or that could interfere with the Study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the Study
• Females who are nursing a child, are pregnant, or who are planning to become pregnant during study drug dosing, or who are not willing to abstain from sex without the use of contraceptive protection during study drug dosing
• Males who do not wish to abstain from sex with women of childbearing potential without use of contraceptive protection during study drug dosing
• Currently taking warfarin or any drug that could cause a coagulopathy event
• Within 1 week of signing informed consent. taking medications that affect insulin activity, including Metformin or Acarbose
• Have an allergy to any active or inactive ingredient of Losartan or Fisetin, and/or currently taking medication with known adverse Losartan or Fisetin interaction
• Within 3 months of signing informed consent have taken senolytic agents including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax;

Where it is running

• The Steadman Clinic — Vail, Colorado, United States

Full record on ClinicalTrials.gov

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