Femoroacetabular ImpingementPhase 1/2NCT05025956
Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan
A Phase 1/2 study testing Fisetin in people with Femoroacetabular Impingement, run by Steadman Philippon Research Institute at 1 site in United States.
Trial summary
The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2021to 31 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 18 and 80 years of age
- Have been diagnosed with femoroacetabular impingement (FAI) and/or a hip labral tear
- You are scheduled to undergo hip arthroscopy to treat FAI and /or a hip labral tear
Who cannot join
- Previous or Planned Hip Surgeries, Procedures and/or Treatments:
- Planned surgery on either the contralateral or target hip at any time during the Study period including dosing and follow-up
- Require microfracture on the target hip as part of the planned arthroscopy
- Within 6 months of signing informed consent, has undergone regenerative hip joint procedures on the target hip including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation
- Have had previous surgery (including microfracture) or diagnostic arthroscopy on the target hip
- Joint space less than ≤2mm
Show all 32Show fewer
- Tönnis Grade 2-3
- Have a history of pigmented villonodular synovitis (joint disease characterized by inflammation and overgrowth of the synovial lining of the hip joint)
- Have a history of synovial chondromatosis (noncancerous tumor that develops in the synovial lining of the hip joint);
- Have a history of hip dysplasia requiring PAO
- History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)
- Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism requiring hormone replacement only, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis
- Current diagnosis of fibromyalgia based on ACR criteria
- Are unable to or are unwilling to receive a PRP injection as part of your surgery
- Inadequate amount of PRP collected to serve the needs of the patient, and/or ProofPoint Biologics
- Within 2 years of signing informed consent, history of active blood clotting disorders requiring preventative treatment, or active malignancy of any type or history of a malignancy (with the exception of subjects with a history of treated basal or squamous cell carcinoma)
- Baseline HbA1C greater than 6.5, uncontrolled diabetes mellitus, and/or medication management has not been stable in the previous 2 months
- Current or prior history of other joint diseases that may (in the opinion of the Principal Clinical Investigator or his/her designee) confound study data or increase Subject risk. These may include including but not limited to joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and/or radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler syndrome, joint infection, hemochromatosis, or neuropathic arthropathy of any cause
- Any medical condition, including findings in laboratory or medical history or in the baseline assessments, that (in the opinion of the Principal Clinical Investigator or his/her designee), constitutes a risk or contraindication for participation in the Study or that could interfere with the Study conduct, endpoint evaluation or prevent the subject from fully participating in all aspects of the Study
- Females who are nursing a child, are pregnant, or who are planning to become pregnant during study drug dosing, or who are not willing to abstain from sex without the use of contraceptive protection during study drug dosing
- Males who do not wish to abstain from sex with women of childbearing potential without use of contraceptive protection during study drug dosing
- Currently taking warfarin or any drug that could cause a coagulopathy event
- Within 1 week of signing informed consent. taking medications that affect insulin activity, including Metformin or Acarbose
- Have an allergy to any active or inactive ingredient of Losartan or Fisetin, and/or currently taking medication with known adverse Losartan or Fisetin interaction
- Within 3 months of signing informed consent have taken senolytic agents including: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax;
- Currently taking the following drugs if they cannot be held for at least 2 days (per enrolling Principal Investigator or Sub Investigator, or healthcare professional appropriately delegated by the Principal Investigator) before and during administration of Fisetin: cyclosporine, tacrolimus, repaglinide, and bosentan
- Currently taking drugs that induce cellular senescence, including alkylating agents, anthracyclines, platins, other chemotherapy
- Within 1 month of signing informed consent, taking a glucocorticoid
- Has current history of drug and/or alcohol abuse
- Within the 3 months of signing informed consent has received anticonvulsant therapy, pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal)
- Within the 12 months prior to signing informed consent received any medications that affect bone turnover, including: adrenocorticosteroids (> 3 months at any time or > 10 days, estrogen (E) therapy or treatment with a selective E receptor modulator, or teriparatide
- Inability to tolerate oral medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Senolytic Agent to Improve the Benefit of Platelet-Rich Plasma and Losartan for Treatment of Femoroacetabular Impingement and Labral Tear: A Pilot Study
The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear.
We believe that giving Fisetin, a senolytic agent, will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP), known to exist in PRP. The main objectives of this study are to determine if pre- and post-operative administration of a senolytic agent will improve the beneficial effects of PRP when used in conjunction with surgical treatment of FAI and/or labral tear, to determine whether pre- and postoperative administration of Fisetin is associated with adverse events, and to determine if pre- and post-operative administration of Fisetin leads to a decrease in systemic senescence, serum SASP, and fibrotic markers.
Patients suffering from femoroacetabular impingement and labral tear, who are planning to undergo hip arthroscopy combined with standard of care intra-operative PRP injection and post-operative losartan administration will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC).
Read the detailed description
This is a pilot, prospective, randomized, double-blind, placebo control clinical trial is proposed to evaluate the safety and efficacy of a senolytic agent (Fisetin) to improve the benefits of standard of care platelet rich plasma (PRP) injection and antifibrotic medication (Losartan) in patients undergoing hip arthroscopy for treatment of femoroacetabular impingement (FAI) and/or labral tear (LT).
- Conditions
- Femoroacetabular Impingement
- Being tested
- Fisetin, Placebo
- Keywords
- FAI Labral tear Fisetin Losartan
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDrug
Also called Novusetin, 7,3',4'-flavon-3-ol, 3,3',4',7-tetrahydroxyflavone
Oral Fisetin 20 mg/kg taken for 8 days total.
PlaceboDrug
Also called Placebo Oral Capsule
Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total.
| Study group | Role | What they receive |
|---|---|---|
| Fisetin group (investigational group) | Experimental | 20mg/kg of Fisetin per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery.
(The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) Receives: Drug: Fisetin |
| Placebo group (control group) | Placebo comparator | 20mg/kg of Placebo per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery.
(The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Occurrence of adverse events
Measured: From date of study drug dosing until the end of the study, an average of 12 months
Secondary outcomes (9)
Patient Reported Outcomes Questionnaire-Modified Harris Hip Score (mHHS)
Consists of 8 questions covering domains of pain, gait, and functional activities. Scored on a 100-point scale, with each answer receiving a specific amount of points. Higher score represents greater hip health.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS)
Includes two subscales to calculate the total score:19 items in the HOS-ADL subscale and 9 items in the HOS-sports subscale.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Scale from 0-96. Higher score represents worse hip health.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Optum Short Form physical and mental component scores (SF-12 PCS and SF-12 MCS)
Includes two subscales to calculate the total score. Higher score represents greater health. Scale standardized to a US Population mean of 50 and standard deviation of 10 points.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Tegner Activity Scale
Scale from 0-10. Higher score represents greater activity level.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Hip Pain
Scale from 1-10. Higher score represents greater hip pain.
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Patient satisfaction with surgical outcome
1-10-point scale
Measured: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood
Concentrations of secreted protein markers found in serum in pg/ml
Measured: Baseline, and 8-12 weeks post-op
Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy
Incidence of revision surgery from day of initial surgery will be recorded
Measured: From day of initial surgery until the end of the study, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start24 Oct 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot, prospective, randomized, double-blind, placebo control clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steadman Philippon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Johnny L Huard, PhD, Principal investigator, Steadman Philippon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025956
- Sponsor's protocol ID
- 2020-058
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Senolytic Agent to Improve the Benefit of Platelet-Rich Plasma and Losartan for Treatment of Femoroacetabular Impingement and Labral Tear: A Pilot Study
- ClinicalTrials.gov ID
- NCT05025956
- Acronym / sponsor ID
- 2020-058
- Conditions
- Femoroacetabular Impingement
- Keywords
- FAI Labral tear Fisetin Losartan
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Steadman Philippon Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to explore the possible benefit of administration of Fisetin, (a senolytic agent) to improve the benefit of Platelet-Rich Plasma and losartan for treatment of femoroacetabular impingement and labral tear.
We believe that giving Fisetin, a senolytic agent, will improve the benefit of PRP by eliminating senescent cells and senescence-associated secretory phenotype (SASP), known to exist in PRP. The main objectives of this study are to determine if pre- and post-operative administration of a senolytic agent will improve the beneficial effects of PRP when used in conjunction with surgical treatment of FAI and/or labral tear, to determine whether pre- and postoperative administration of Fisetin is associated with adverse events, and to determine if pre- and post-operative administration of Fisetin leads to a decrease in systemic senescence, serum SASP, and fibrotic markers.
Patients suffering from femoroacetabular impingement and labral tear, who are planning to undergo hip arthroscopy combined with standard of care intra-operative PRP injection and post-operative losartan administration will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC).
Detailed description
This is a pilot, prospective, randomized, double-blind, placebo control clinical trial is proposed to evaluate the safety and efficacy of a senolytic agent (Fisetin) to improve the benefits of standard of care platelet rich plasma (PRP) injection and antifibrotic medication (Losartan) in patients undergoing hip arthroscopy for treatment of femoroacetabular impingement (FAI) and/or labral tear (LT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot, prospective, randomized, double-blind, placebo control clinical trial
| Arm | Type | Receives |
|---|---|---|
| Fisetin group (investigational group) | Experimental | Drug: Fisetin20mg/kg of Fisetin per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery. (The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) |
| Placebo group (control group) | Placebo comparator | Drug: Placebo20mg/kg of Placebo per day for days 1 and 2 prior to surgery and days 33, 34, 63, 64, 93, and 94 post surgery. (The pills are 100mg each. For example, if a participant weighs 160 pounds (about 73 kg), the participant will need to take 15 pills per day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 18 and 80 years of age
- Have been diagnosed with femoroacetabular impingement (FAI) and/or a hip labral tear
- You are scheduled to undergo hip arthroscopy to treat FAI and /or a hip labral tear
Key exclusion criteria (32 listed)
- Previous or Planned Hip Surgeries, Procedures and/or Treatments:
- Planned surgery on either the contralateral or target hip at any time during the Study period including dosing and follow-up
- Require microfracture on the target hip as part of the planned arthroscopy
- Within 6 months of signing informed consent, has undergone regenerative hip joint procedures on the target hip including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation
- Have had previous surgery (including microfracture) or diagnostic arthroscopy on the target hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinAlso: Novusetin, 7,3',4'-flavon-3-ol, 3,3',4',7-tetrahydroxyflavoneOral Fisetin 20 mg/kg taken for 8 days total. | Drug | Fisetin group (investigational group) |
| PlaceboAlso: Placebo Oral CapsuleFisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total. | Drug | Placebo group (control group) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From date of study drug dosing until the end of the study, an average of 12 months
Occurrence of adverse events
9 secondary outcomes
Patient Reported Outcomes Questionnaire-Modified Harris Hip Score (mHHS)
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire- Hip Outcome Score: activities of daily living and sports subscales (HOS-ADL, HOS-SSS)
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Optum Short Form physical and mental component scores (SF-12 PCS and SF-12 MCS)
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Tegner Activity Scale
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Hip Pain
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Patient Reported Outcomes Questionnaire-Patient satisfaction with surgical outcome
Time frame: Baseline, 8-12 weeks post-op, 6 months post-op, and 12 months post-op
Multi and singleplex immunoassays and flow cytometry senescence and SASP marker assessment of peripheral blood
Time frame: Baseline, and 8-12 weeks post-op
Incidence of revision arthroscopy or other hip surgery required post initial arthroscopy
Time frame: From day of initial surgery until the end of the study, an average of 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnny L Huard, PhD principal investigator
Steadman Philippon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fisetin in people with Femoroacetabular Impingement, run by Steadman Philippon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From date of study drug dosing until the end of the study, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.