Senolytic + Anti-Fibrotic Agents for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byScott L Tashman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Steadman Philippon Research Institute

Trial Summary

What is the purpose of this trial?

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.

Research Team

Johnny Huard, PhD

Principal Investigator

Steadman Philippon Research Institute

Marc Philippon, MD

Principal Investigator

Steadman Philippon Research Institute

Scott L Tashman, PhD

Principal Investigator

Steadman Philippon Research Institute

Eligibility Criteria

This trial is for ambulatory adults aged 40-85 with osteoarthritis in at least one knee, experiencing a certain level of pain. They must be able to consent and follow the study procedures. Excluded are those taking Losartan or Fisetin, anticoagulants like Warfarin, have had recent knee surgery or injections, pregnant women, individuals unable to undergo an MRI, and those with various health conditions that could interfere with the study.

Inclusion Criteria

My knee pain scores between 3 to 10, and the other knee hurts 2 points less.

I can understand and agree to the study's procedures on my own.

I have knee osteoarthritis that affects my ability to move.

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Exclusion Criteria

I had a knee scope or surgery on my target knee within the last 6 months.

I have had a knee regeneration procedure in the last 6 months.

Unable to safely undergo an MRI based on MRI safety screening (for example, due to incompatible device/implant, severe claustrophobia, BMI greater than 40 kg/m2, or size exceeding the limits of the of the MRI equipment (coil and gantry))

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Treatment Details

Interventions

Fisetin (Senolytic Agent)
Losartan (Anti-Fibrotic Agent)

Trial OverviewThe trial tests the safety and effectiveness of Fisetin (a senolytic agent) and Losartan (an anti-fibrotic agent), alone or combined, compared to bone marrow stem cell injections into the knee. It's randomized and double-blind meaning participants won't know which treatment they receive.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active Fisetin and Active LosartanExperimental Treatment2 Interventions

Losartan 12.5 mg, PO, BID beginning the first day after BMA Concentrate injection and continuing for 30 days. Fisetin 20mg/kg taken a total of 4 days prior to BMA Concentrate injection (-32 and -31 and -3 and -2) then again after BMA Concentrate injection a for a total of 6 days (32 \& 33, 61 \& 62 and 90 \& 91).

Group II: Fisetin Placebo and Active LosartanActive Control2 Interventions

Losartan 12.5 mg, PO, BID beginning the first day after BMA Concentrate injection and continuing for 30 days. Fisetin Placebo 20mg/kg taken a total of 4 days prior to BMA Concentrate injection (-32 and -31 and -3 and -2) then again after BMA Concentrate injection a for a total of 6 days (32 \& 33, 61 \& 62 and 90 \& 91).

Group III: Active Fisetin and Losartan PlaceboActive Control2 Interventions

Losartan Placebo 12.5 mg, PO, BID beginning the first day after BMA Concentrate injection and continuing for 30 days. Fisetin 20mg/kg taken a total of 4 days prior to BMA Concentrate injection (-32 and -31 and -3 and -2) then again after BMA Concentrate injection a for a total of 6 days (32 \& 33, 61 \& 62 and 90 \& 91).

Group IV: ControlPlacebo Group2 Interventions

Losartan placebo 12.5 mg, PO, BID beginning the first day after BMA Concentrate injection and continuing for 30 days. Fisetin Placebo 20mg/kg taken a total of 4 days prior to BMA Concentrate injection (-32 and -31 and -3 and -2) then again after BMA Concentrate injection a for a total of 6 days (32 \& 33, 61 \& 62 and 90 \& 91).