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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
My knee pain scores between 3 to 10, and the other knee hurts 2 points less.
Select...
I can understand and agree to the study's procedures on my own.
Select...
My knee pain scores between 3 to 10, and the other knee hurts 2 points less.
Select...
I have knee osteoarthritis that affects my ability to move.
Select...
I am between 40 and 85 years old.
Select...
I can walk and have moderate to severe arthritis in my knee.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, 14 days post-injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, 14 days post-injection, 30 days post injection, 3 months post injection, 6 months post injection, 12 months post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Secondary outcome measures
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 more

Side effects data

From 2022 Phase 2 trial • 55 Patients • NCT04771611
7%
Rash
7%
Chest pain
7%
Diarrhea
7%
Sinusitis
7%
Infectious Rash
7%
Back Pain
7%
Headache
7%
Worsening Headache
7%
Dyspnea
7%
sore throat
7%
hyperhidrosis
3%
tachycardia
3%
shortness of breath
3%
ageusia
3%
amnesia
3%
change in smell
3%
ear pain, left
3%
vomiting
3%
edema, hand, bilateral
3%
fatigue
3%
flu like symptoms
3%
Otitis media
3%
Upper Respiratory Infection
3%
Anosmia
3%
Colic Renal
3%
Nephrolithiasis Calcium Oxalate
3%
Epistaxis
3%
cough
3%
rhinitis
3%
sneezing
3%
thrush
3%
right shoulder arthroscopy, rotator cuff, repair
3%
asthma with exacerbation
3%
watering eyes (epiphora)
3%
flatulence
3%
conjunctivitis
3%
migraine
3%
bacterial vaginosis
3%
arthoplasty
3%
vertigo
3%
Systolic murmur
3%
hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group
Placebo

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
~200
Losartan
2003
Completed Phase 4
~3000

Find a Location

Who is running the clinical trial?

Steadman Philippon Research InstituteLead Sponsor
9 Previous Clinical Trials
515 Total Patients Enrolled
1 Trials studying Osteoarthritis
75 Patients Enrolled for Osteoarthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,846 Total Patients Enrolled
50 Trials studying Osteoarthritis
46,888 Patients Enrolled for Osteoarthritis
Scott L Tashman, PhDPrincipal InvestigatorSteadman Philippon Research Institute

Media Library

Fisetin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04815902 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements for participants in this research?

"The study requires 100 individuals with osteoarthritis in their knees, aged between 40-85. These candidates must report a pain score of 3-10 on the target knee and a difference of at least 2 points compared to the contralateral knee within the past week."

Answered by AI

How many people are taking part in this experiment at most?

"That is correct. The information available on clinicaltrials.gov supports that this study is presently recruiting patients. This trial was first advertised on May 18th, 2021 and has been updated as recently as October 6th, 2022. The research team needs to enroll 100 individuals from 1 participating hospital or medical facility."

Answered by AI

Is this research still looking for participants?

"The clinical trial is currently looking for patients, as seen on clinicaltrials.gov. This specific trial was originally posted on May 18th, 2021 and was most recently edited on October 6th, 2022."

Answered by AI

Can you provide more information on other investigations utilizing Fisetin?

"At this moment, there are 36 different ongoing trials investigating Fisetin. Out of these, 2 have reached Phase 3. The preponderance of these studies are situated in San Francisco; however, 538 other medical locations are also running similar research."

Answered by AI

Why is Fisetin often given to patients?

"Fisetin has potential therapeutic benefits for diabetic nephropathy patients. Additionally, it is sometimes used to mitigate the symptoms of left ventricular hypertrophy, proteinuria, and hypertensive disease."

Answered by AI

Are people over the age of 20 able to participate in this trial phase?

"This particular study is only open to people aged 40 to 85. In contrast, there are 43 clinical trials aimed at patients under 18 and 724 studies for individuals over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
What site did they apply to?
The Steadman Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. The Steadman Clinic: < 24 hours
Average response time
  • < 1 Day
~23 spots leftby Feb 2025