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Amniotic Suspension Allograft for Knee Osteoarthritis

Phase 3

Recruiting

Research Sponsored by Organogenesis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you failed to adequately respond for at least 6 months to at least two therapies within the last 12 months for the treatment of OA [Note: this includes acetaminophen, exercise, weight loss, physical therapy, NSAIDS (oral or topical), or corticosteroids]

Do you have pain when walking on a flat surface, going up and down stairs, or pain while you are sleeping?

Must not have

Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study

Any symptoms of locking of the knee or limited range of motion, or loose body sensation?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 26

Awards & highlights

Study Summary

This trial examines if a painkiller can help relieve knee pain caused by OA.

Who is the study for?

Adults over 18 with a BMI under 40 and moderate to severe knee osteoarthritis, who haven't responded well to other treatments for at least six months. Participants must not be on immunosuppressives or have recent knee injuries/surgeries, infections, or conditions that could affect safety or data quality. They should use birth control if applicable.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Amniotic Suspension Allograft (ASA) against a placebo in reducing knee pain from osteoarthritis. Patients will randomly receive either ASA or an inactive substance to compare outcomes.See study design

What are the potential side effects?

While specific side effects are not listed, potential risks may include allergic reactions to ASA components, infection at the injection site, increased knee pain or swelling post-injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had knee surgery in the past year and do not plan to during the study.

Timeline

Screening ~ 3 weeks1 visit

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients

Secondary outcome measures

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 WOMAC Pain at 3 months

The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months

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

0 / 5Eligibility criteria met

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

OrganogenesisLead Sponsor

35 Previous Clinical Trials

3,796 Total Patients Enrolled

3 Trials studying Osteoarthritis

684 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

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

Is Acetylsalicylic Acid (ASA) generally tolerated well by individuals?

"Our assessment of ASA's safety is a 3, as there are multiple rounds of data that both confirm its efficacy and certify its safety."

Answered by AI

What is the total population size for this research endeavor?

"Affirmative. Information on clinicaltrials.gov shows that this trial, which was originally posted on September 6th 2023, is actively enrolling patients. Approximately 474 individuals need to be recruited from 2 distinct medical centres."

Answered by AI

Is enrollment for this research project still ongoing?

"According to clinicaltrials.gov, this investigation into potential medical treatments is currently in need of participants. It was first posted on September 6th 2023 and the information was last updated a week later."

Answered by AI

Who else is applying?

What site did they apply to?

Chicago Clinical Research Institute Inc.

Central Research Associates, Inc.

NYU Langone Health

Other

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I've been 2 years in pain , have done physical therapy, and hyaluronic injection.

PatientReceived no prior treatments

I previously had a prp which only worked for 6 to 8 weeks, I tried PT, and 3 antii inflamatories without success, my activity level is decreasing, and my stiffness is increasing, I have pain earlier in the day.

PatientReceived 1 prior treatment

Number one I really want to get some done about my knees the actual doctors that handled me they gave me shots here and there but they've done nothing really they gave me gabapentin which is a muscle relaxer to help the pain and it was it they ain't done nothing they told both to my knees in it you got it they said it's really bad I got arthritis in my hands and stuff I got alternative order and I got it in my heel so when I seen this study it motivated me to want to be a part of something that can help no one can help me understand what why I hurt so bad maybe can help me find a cure to it or something I can do to make it better and I can be a part of something just helping other people and it's something I'm there doing that you know I'm learning about and this is fascinating to me so I definitely want to be a part of it so I just hope you all accept me and we can work together and you can help me and hopefully whatever I do is helping you too God bless Raymond Newsome.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

2023. "A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000410.

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