NCT05025956

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

Active, enrolled Phase 1, PHASE2 Last updated 16 April 2024

What this trial tests

Phase 1, PHASE2 trial testing Fisetin in Femoroacetabular Impingement in 68 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 October 2021

Primary endpoint
31 October 2024

31 October 2024

Quick facts

Lead sponsor	Steadman Philippon Research Institute
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	68
Start date	24 October 2021
Primary completion	31 October 2024
Estimated completion	31 October 2024
Sites	1 location across United States

Drugs / interventions tested

• Fisetin — full drug profile →
• Placebo

Conditions studied

• Femoroacetabular Impingement — all drugs for Femoroacetabular Impingement →

Sponsor

Steadman Philippon Research Institute

Who can join

Adults 18 to 80, any sex, with Femoroacetabular Impingement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cellular senescence and senolytics: the path to the clinic.
   Chaib S, Tchkonia T, Kirkland JL. · · 2022 · cited 818× · PMID 35953721 · DOI 10.1038/s41591-022-01923-y
2. Potential Role of Polyphenolic Flavonoids as Senotherapeutic Agents in Degenerative Diseases and Geroprotection.
   Mbara KC, Devnarain N, Owira PMO. · · 2022 · cited 40× · PMID 36100824 · DOI 10.1007/s40290-022-00444-w
3. Recent Advances in Aging and Immunosenescence: Mechanisms and Therapeutic Strategies.
   Wang S, Huo T, Lu M, Zhao Y, et al · · 2025 · cited 20× · PMID 40214453 · DOI 10.3390/cells14070499
4. Drugs Targeting Mechanisms of Aging to Delay Age-Related Disease and Promote Healthspan: Proceedings of a National Institute on Aging Workshop.
   Espinoza SE, Khosla S, Baur JA, de Cabo R, et al · · 2023 · cited 19× · PMID 37325957 · DOI 10.1093/gerona/glad034
5. Nanocarriers for natural polyphenol senotherapeutics.
   Joma N, Bielawski PB, Saini A, Kakkar A, et al · · 2024 · cited 17× · PMID 38685568 · DOI 10.1111/acel.14178
6. Senescence in the bone marrow microenvironment: A driver in development of therapy-related myeloid neoplasms.
   Guilatco AJ, Shah MV, Weivoda MM. · · 2024 · cited 3× · PMID 39072049 · DOI 10.1016/j.jbo.2024.100620
7. The potential for senotherapy as a novel approach to extend life quality in veterinary medicine.
   Williams ZJ, Chow L, Dow S, Pezzanite LM. · · 2024 · cited 3× · PMID 38812556 · DOI 10.3389/fvets.2024.1369153
8. Effects of oral losartan administration on homeostasis of articular cartilage and bone in a rabbit model.
   Deng Z, Gao X, Utsunomiya H, Arner JW, et al · · 2022 · cited 3× · PMID 35372645 · DOI 10.1016/j.bonr.2022.101526