Amniotic Suspension Allograft for Arthrosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Arthrosis+2 More
Amniotic Suspension Allograft - Biological
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

2 of 3
This is further along than 85% of similar trials

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

3 of 3
This is further along than 85% of similar trials

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: Biological
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: October 22nd, 2022

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?
Louisiana50.0%
California50.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
AMR Mobile50.0%
Horizon Clinical Research Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%