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Senolytic + Anti-Fibrotic Agents for Osteoarthritis
Phase 1 & 2
Waitlist Available
Led By Scott L Tashman, PhD
Research Sponsored by Steadman Philippon Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Baseline pain of 3-10 points on the target knee and a pain differential of at least -2 points on the contralateral knee as exhibited by the worst pain score (on the 11-point Numeric Rating Scale) for the previous week.
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
Must not have
Within 6 months of signing informed consent has undergone regenerative knee joint procedures including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation, autologous chondrocyte transplantation, or mosaicplasty
Within 3 months of signing informed consent have taken senolytic agents including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up subjects may receive alternative treatment at any point during the 18-month study, continued participation will be determined on an individual basis (the time to resort to alternative therapy from baseline will be recorded)
Awards & highlights
Summary
This trial is testing whether a senolytic agent (Fisetin) and an anti-fibrotic agent (Losartan), used independently or in combination, can improve the beneficial effect of an active control (injection of autologous bone marrow aspirate concentrate (BMAC) into an osteoarthritic knee).
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include allergic reactions to Fisetin or Losartan ingredients; interactions with other medications; changes in blood pressure due to Losartan; gastrointestinal issues from either drug; fatigue; headaches; dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain scores between 3 to 10, and the other knee hurts 2 points less.
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I can understand and agree to the study's procedures on my own.
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I have knee osteoarthritis that affects my ability to move.
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I am between 40 and 85 years old.
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I can walk and have moderate to severe arthritis in my knee.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a knee regeneration procedure in the last 6 months.
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I have taken senolytic agents like Fisetin or Quercetin in the last 3 months.
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I have not taken senolytic agents like Fisetin or Dasatinib in the last 3 months, or I am willing to stop taking them for the study.
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I cannot take medicine by mouth.
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I am currently on Lithium medication.
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I haven't taken any medications that affect bone turnover in the last 12 months.
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I am a male willing to use contraception during the study.
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I am scheduled for knee surgery on the other or affected knee during the study.
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I have been diagnosed with diabetes according to the American Diabetes Association.
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I've had a knee injection with steroids or hyaluronic acid in the last 12 weeks.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I have been diagnosed with fibromyalgia.
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I have used opioid painkillers in the last 8 weeks and cannot stop during the study.
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I haven't had blood disorders or any cancer except skin cancer in the last 2 years.
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I am not taking, or willing to stop taking, drugs that cause significant cellular stress.
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I am currently on Warfarin or similar blood thinners.
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I am currently taking Losartan.
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I have taken opioid painkillers in the last 8 weeks and cannot stop during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ subjects may receive alternative treatment at any point during the 18-month study, continued participation will be determined on an individual basis (the time to resort to alternative therapy from baseline will be recorded)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subjects may receive alternative treatment at any point during the 18-month study, continued participation will be determined on an individual basis (the time to resort to alternative therapy from baseline will be recorded)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Change in CTX-II as compared to placebo in urine
Change in associate biomarkers as compared to placebo in peripheral blood plasma/serum
Change in levels of senescent PBMCS (total and specific PBMC subsets such as T-Cells)
+16 moreSide effects data
From 2023 Phase 1 & 2 trial • 75 Patients • NCT0421098638%
Arthralgia
15%
Pain in Extremity
12%
Nausea
12%
Lab Findings
9%
Back Pain
9%
Fatigue
9%
Headache
6%
Flatulence
6%
Muscle Cramp
6%
Dry Mouth
6%
Rash Maculo-Papular
3%
Bladder Perforation
3%
Covid 19
3%
Neoplasms
3%
Rotator Cuff Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fisetin
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisetin
2016
Completed Phase 2
~250
Losartan
2003
Completed Phase 4
~3000
Find a Location
Who is running the clinical trial?
Steadman Philippon Research InstituteLead Sponsor
10 Previous Clinical Trials
602 Total Patients Enrolled
1 Trials studying Osteoarthritis
75 Patients Enrolled for Osteoarthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
494 Previous Clinical Trials
1,089,342 Total Patients Enrolled
51 Trials studying Osteoarthritis
46,936 Patients Enrolled for Osteoarthritis
Scott L Tashman, PhDPrincipal InvestigatorSteadman Philippon Research Institute
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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