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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 0 days
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 weeks
Treatment ~ Varies
Follow Up ~0 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 days 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Osteoarthritis (OA) often involve the inhibition of cyclooxygenase (COX) enzymes, which reduces the production of prostaglandins, thereby decreasing inflammation and pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen are typical examples. Additionally, treatments targeting inflammatory pathways, such as TNF-alpha inhibitors, aim to reduce the destruction of the articular matrix. These mechanisms are crucial for OA patients as they help manage symptoms, improve joint function, and potentially slow disease progression, enhancing overall quality of life.
Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis.Pathophysiology and first-line treatment of osteoarthritis.

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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
~309 spots leftby Sep 2025
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