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Amniotic Suspension Allograft for Osteoarthritis
Phase 3
Waitlist Available
Research Sponsored by Organogenesis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new treatment called ASA, which is injected directly into the knee joint. It aims to help patients with knee osteoarthritis by reducing pain and improving joint function. The study will compare the effects of ASA over several months.
Eligible Conditions
- Osteoarthritis of the Knee
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aspirin
Secondary study objectives
Incidence of adverse events (AEs)
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
+7 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ASAExperimental Treatment1 Intervention
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a single IA injection of 4 mL of normal saline
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Who is running the clinical trial?
OrganogenesisLead Sponsor
36 Previous Clinical Trials
3,966 Total Patients Enrolled
2 Trials studying Osteoarthritis
210 Patients Enrolled for Osteoarthritis
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- may be jurors
People who are 18 years or older and are either male or female may serve on a jury.You have received a corticosteroid injection in your knee within the past 3 months before the screening.Your screening tests or physical examination show important health issues that are not specifically related to knee osteoarthritis. These issues could affect the study or make it harder to understand the results, or they may increase your risk as a participant.You have received injections or treatments for your knee within the past 6 months, such as hyaluronic acid, platelet-rich plasma, or other substances derived from your own body or from others.You take blood-thinning medication regularly.You are allergic to aspirin or any of its ingredients.You have injured your knee severely within the past 3 months.Your pain score on the WOMAC Pain scale for the past 7 days is 11 or higher.Your body weight is within a healthy range based on your height.You have symptoms like your joint getting stuck, a feeling of something blocking movement, or a sensation of something loose inside your joint, which could suggest a problem with your meniscus or loose material in your joint.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.Your body weight is within a healthy range (BMI less than 40 kg/m²).You have tried at least two different treatments for your joint pain, including exercise, weight loss, and over-the-counter painkillers like acetaminophen and NSAIDs, for at least six months, but they did not work well enough.You agree to not use illegal drugs during the study and to be tested for illegal drug use if there are any suspicions.You have had consistent and significant pain in your other knee, scoring at least 4 on a pain scale, for most days in the last week.You have tried at least two different treatments for osteoarthritis that include exercise, weight loss, physical therapy, and over-the-counter pain medications like acetaminophen and nonsteroidal anti-inflammatory drugs, but they have not provided enough relief for at least 6 months.You agree not to use illegal drugs during the study and agree to be tested for illegal drug use if suspected.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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ASA
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04636229 — Phase 3
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