NCT04815902

Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis

The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Steadman Philippon Research Institute · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blind, active control clinical trial to evaluate the safety and efficacy of a senolytic agent (Fisetin) and an anti-fibrotic agent (Losartan), used independently and in combination, to improve beneficial effect demonstrated by the active control which is to be injection of autologous bone marrow aspirate concentrate (BMAC) into an osteoarthritic knee.

Detailed description

This is a prospective, randomized, double-blind, active control clinical trial to evaluate the safety and efficacy of a senolytic agent (Fisetin) and an anti-fibrotic agent (Losartan), used independently and in combination, to improve beneficial effect demonstrated by the active control which is to be injection of autologous bone marrow aspirate concentrate (BMAC) into an osteoarthritic knee. 100 subjects with symptomatic unilateral or bilateral knee osteoarthritis (Kellgren-Lawrence grade II-IV) will be randomized into one of four arms (1:1:1:1). All subjects will receive an injection of BMAC. Group 1-n=25: Control (BMA concentrate + Fisetin Placebo + Losartan Placebo) Group 2-n=25: BMA concentrate + Fisetin Placebo + Active Losartan Group 3-n=25: BMA concentrate + Active Fisetin + Losartan Placebo Group 4-n=25: BMA concentrate + Active Fisetin + Active Losartan

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Fisetin	Oral Fisetin 20 mg/kg taken for 10 days total.
DRUG	Losartan	12.5 mg oral Losartan taken for 30 days total.
DRUG	Placebo - Losartan	Losartan appearance-matched microcrystalline cellulose placebo. 12.5 taken for 30 days total.
DRUG	Placebo Fisetin	Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 10 days total.

Timeline

• Start date: 2021-05-18
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2021-03-25
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study