What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs and glucocorticoids, work by inhibiting COX enzymes to reduce inflammation and pain. NSAIDs, including ibuprofen, naproxen, and celecoxib, can cause gastrointestinal issues (e.g., ulcers, bleeding), cardiovascular risks (e.g., heart attack, stroke), and renal side effects (e.g., kidney damage). Glucocorticoids, used for their anti-inflammatory effects, may lead to weight gain, osteoporosis, hypertension, and increased infection risk. While these treatments alleviate symptoms, they do not stop the progression of osteoarthritis.

What prior FDA approvals exist?

The FDA has approved several COX-2 selective inhibitors for the treatment of osteoarthritis, which work by reducing prostaglandin production to decrease inflammation and pain. Notable examples include celecoxib, which was approved for osteoarthritis and rheumatoid arthritis, and rofecoxib, which was also approved for similar indications but later withdrawn from the market due to safety concerns. These drugs offer an alternative to nonselective NSAIDs by providing pain relief with a potentially lower risk of gastrointestinal side effects.

What other types of research exist?

Promising novel alternatives to ASA for osteoarthritis treatment in 2024 include: 1) Amniotic Suspension Allograft (ASA), which is being evaluated for its efficacy and safety in managing OA symptoms. 2) TNF inhibitors like infliximab, etanercept, adalimumab, certolizumab, and golimumab, which have shown substantial improvements in disease activity and function in related conditions. 3) New herbal compositions such as OA-F2, which have demonstrated anti-osteoarthritic potential in preclinical studies. These alternatives offer different mechanisms of action and potential benefits compared to traditional NSAIDs.

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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

Pivotal Trial

Summary

This trial is testing if injecting ASA into the knee can help people with knee osteoarthritis feel better. The study will check pain levels, knee function, and safety over several months. ASA (Amniotic Suspension Allograft) has been shown to be an effective treatment for knee osteoarthritis in previous studies.

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.

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.

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 ~ 0 days0 visits

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & 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

0 / 5Eligibility criteria met

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.