Fisetin for Arthrosis

Phase-Based Estimates
1
Effectiveness
1
Safety
The Steadman Clinic, Vail, CO
Arthrosis+1 More
Fisetin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Arthrosis

Study Summary

This study is evaluating whether a combination of two drugs may help treat osteoarthritis.

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Eligible Conditions

  • Arthrosis
  • Osteoarthritis
  • Osteoarthritis, Knee

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Fisetin will improve 1 primary outcome and 19 secondary outcomes in patients with Arthrosis. Measurement will happen over the course of 32 days post baseline.

Month 12
Change in muscle strength of the study knee
Change in physical function of the Study Knee (LEK)
Change in physical function of the Study Knee (TUG)
Change in physical function of the Study Knee (fast 40-meter walk)
Month 12
Morphological and Quantitative Magnetic Resonance Imaging (MRI)
Month 12
Change in physical function of the Study Knee (6-minute walk test)
Change in physical function of the Study Knee (Stair Test)
32 days post baseline
Characterization of Bone Marrow Derived Aspirate Concentrate cell content prior to injection
Characterization of Bone Marrow Derived plasma biomarkers prior to injection
Month 12
Change in CTX-II as compared to placebo in urine
Change in synovial fluid content
Month 12
Incidence of Treatment-Emergent Adverse Events
Month 4
Patient-Reported Outcome Questionnaires
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)
Change in time to conversion to alternative treatment
Month 12
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)
Month 18
Evaluation of patient reported outcome (PRO) for knee functions (IKDC)
Evaluation of patient reported outcome (PRO) for knee functions (Tegner)
Evaluation of patient reported outcome (PRO) for knee functions (WOMAC)
Evaluation of patient reported outcome (PRO) for quality of life

Trial Safety

Trial Design

4 Treatment Groups

Active Fisetin and Losartan Placebo
Active Fisetin and Active Losartan
Placebo group

This trial requires 100 total participants across 4 different treatment groups

This trial involves 4 different treatments. Fisetin is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Active Fisetin and Active LosartanLosartan 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).
Active Fisetin and Losartan PlaceboLosartan 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).
Fisetin Placebo and Active LosartanLosartan 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).
ControlLosartan 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
Losartan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 32 days - 3 months prior to injection, 6 months post injection, 12 months post injection for reporting.

Closest Location

The Steadman Clinic - Vail, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ambulatory persons with osteoarthritis (OA) of at least one knee (Kellgren-Lawrence grade II-IV);
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;
Between 40 and 85 years of age;

Patient Q&A Section

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

Is fisetin typically used in combination with any other treatments?

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Fisetin is a small molecule derived from flaxseed that has been used as an oral antioxidant. In addition to this, other studies have shown that it plays a role in blood pressure regulation, which is interesting considering its effect on inflammation. Findings from a recent study also shows the ability of fisetin to improve the functionality of articular joints in vitro.

Unverified Answer

What are the signs of arthrosis?

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Arthrosis is a condition where a bone becomes diseased and deformed. This condition causes pain and can lead to difficulty for the person to do things like stand, walk, sleep, and bend. There are different types of symptoms that people with arthrosis must deal with, such as pain. Even though these symptoms do not affect how the person interacts with the world, they hurt them. A lot of time is spent on managing the pain and trying to fix the bone.\n\nThere are many different ways to prevent and treat arthritis (arthritis is an inflammation of a joint). The best method of treatment depends on the type of arthritis the person has.

Unverified Answer

What is arthrosis?

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Arthrosis is the condition of joints that can result from chronic inflammation and can cause joint pain, swelling, restriction and stiffness. Arthritis-like symptoms can often be observed in those without joint disease, although these symptoms are generally milder than in joint disease, and may also be the first symptoms of arthritis.

Unverified Answer

What causes arthrosis?

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Arthrosis appears to be a multi-factorial disease with contributions from multiple risk factors. However, smoking remains the most significant risk factor and it is probably the major cause of early arthrosis.

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How many people get arthrosis a year in the United States?

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Around 30 million people have at least one type of joint discomfort in the US. This is 7 times more people than are diagnosed with arthritis. Only around 50% of those who experience a joint worry or feel pain get an exam with a healthcare professional.

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Can arthrosis be cured?

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In patients with acute knee instability, successful treatment of the associated arthrosis is reported to be possible. However, most patients do not make excellent responders to this treatment. In persistent cases, additional arthrodialytic therapy may be useful.

Unverified Answer

What are common treatments for arthrosis?

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There is little evidence available for many arthritis treatments and alternatives, such as acupuncture, chiropractic, massage, orthotics and lifestyle, are often used. Although there is a vast number of alternative treatments, they may still represent the most common treatments for arthritis.

Unverified Answer

What is fisetin?

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Fisetin is the most abundant flavonol and can be found in foods such as tea, soy, onion, egg, apple peel, pomegranate, cocoa, bilberry, spinach, broccoli, and broccoli sprouts. It has many health benefits, including antitumor, antioxidant, and anti-inflammatory activities. In the present study, fisetin exhibited anti-inflammatory effect, inhibiting the expressions of c-Jun N-terminal kinase, p38 mitogen-activated protein kinase, and nuclear factor-kB, and consequently down-regulating inflammatory factors, including TNF-α and IFN-γ.

Unverified Answer

How does fisetin work?

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It is proposed that fisetin reduces osteoclast-related bone resorption by inactivating ROS formation and inhibiting the Akt pathway in osteoclasts via the down-regulation of NFATc1 and NFATc2.

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How serious can arthrosis be?

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Arthrosis is an oft neglected chronic inflammatory joint disease, which involves cartilage loss that is irreversible and is associated with a significant and often severe negative impact on the individual's quality of life. It is important to recognize the many possible signs and symptoms of arthrosis, especially to recognize the presence of pain at any stage of arthritis.

Unverified Answer

Have there been other clinical trials involving fisetin?

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To our knowledge, this is the first review to provide evidence of clinical trials for fisetin safety and efficacy for various musculoskeletal indications including osteoarthritis.

Unverified Answer

What does fisetin usually treat?

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Fisetin is one of the most widely used herbal medicine in many herbal products due to its effects in reducing inflammation. But, fisetin has been suggested to cause side-effects due to its multiple actions such as inhibition of 5'-lipoxygenase activity and enhancement of 5'-hydroperoxidase activity. Thus, it is essential to consider the possible side effects of fisetin before it can be used for treatments. Data from a recent study, the side effect and possible interactions of fisetin on the production of PGE2 and the expression of EP4 receptor have been demonstrated in THP-1 cells and C3H10T1/2 cells and we suggest a possible approach for treating arthritis.

Unverified Answer
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