Amniotic Suspension Allograft for Arthrosis
Phase-Based Progress Estimates
Effectiveness
Safety
Arthrosis+2 More
Amniotic Suspension Allograft - BiologicalEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing if aspirin is effective and safe for treating osteoarthritis symptoms in the knee.
Eligible Conditions
- Arthrosis
- Knee
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Other trials for Arthrosis
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Baseline to Week 52
Baseline to Week 12
The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months
The difference between changes from baseline for ASA- and placebo- treated patients in the WOMAC Total at 3 months
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 3 months
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Stiffness at 3 months
Baseline to Week 26
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Total at 6 months
Aspirin
Baseline to Week 52
Incidence of adverse events (AEs)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Other trials for Arthrosis
Trial Design
2 Treatment Groups
ASA
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
474 Total Participants · 2 Treatment Groups
Primary Treatment: Amniotic Suspension Allograft · Has Placebo Group · Phase 3
ASA
Biological
Experimental Group · 1 Intervention: Amniotic Suspension Allograft · Intervention Types: BiologicalPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 52
Who is running the clinical trial?
Premier Research Group plcIndustry Sponsor
55 Previous Clinical Trials
33,389 Total Patients Enrolled
OrganogenesisLead Sponsor
34 Previous Clinical Trials
3,322 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:by means of diuretics
Patients who have failed to adequately respond to at least 2 therapies that include conservative, non-pharmacological therapy (e.g.
If you are a man who is not surgically sterile and you want to be in the study, you must agree to use contraception from Day 1 through 12 months after you get the treatment.
She was able to keep up with the study requirements and go through all the protocol-related procedures, including post-hospitalization, out-patient, and follow-up visits.
This person is willing to not use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study.
may be jurors
People who are 18 years or older and are either male or female may serve on a jury.
The patient has OA of the knee with a Kellgren and Lawrence radiographic classification of Grade 2-4, confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation
The patient reports having an overall pain score of 11 or more over the past seven days on the WOMAC Pain Scale.
Must be female, surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment.
You have a diagnosis of OA of the knee by a combination of clinical and radiographic findings.
You have a body mass index (BMI) of less than 40 kg/m².
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Louisiana | 50.0% |
| California | 50.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| AMR Mobile | 50.0% |
| Horizon Clinical Research Center | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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