What side effects are associated with this type of intervention?

Common treatments for meniscus tears include partial meniscectomy, meniscal repair, and non-surgical care such as physical therapy. Partial meniscectomy can lead to side effects like knee stiffness, swelling, and a higher risk of osteoarthritis over time. Meniscal repair, while preserving more of the meniscus, carries risks such as infection, nerve damage, and the potential for the repair not to heal properly, necessitating further surgery. Non-surgical treatments generally have fewer side effects but may not be as effective in severe cases. The investigational treatment AM3101 aims to enhance meniscal healing and reduce complications, potentially offering a safer alternative with fewer long-term risks.

What prior FDA approvals exist?

The FDA has approved various treatments for meniscus tears, primarily focusing on surgical interventions such as meniscectomy and meniscal repair. Non-surgical treatments include intra-articular injections of hyaluronic acid and other viscosupplementation therapies, which aim to reduce pain and improve joint function. Additionally, investigational approaches like the use of glycosaminoglycan polysulfuric acid ester have shown promise in experimental models for preventing cartilage erosion and promoting repair. These treatments aim to facilitate meniscal healing and reduce the incidence of non-healing complications.

What other types of research exist?

Promising novel alternatives to AM3101 for meniscus tear treatment include: <ol> <li>Gene therapy approaches, such as the use of interleukin-1 receptor antagonists, which have shown potential in early experimental osteoarthritis models.</li> <li></li> </ol> Biological agents like fibroblast growth factor-18 (FGF-18), which stimulates chondrogenesis and cartilage repair. 3. Matrix metalloproteinase inhibitors, which target enzymes involved in cartilage degradation. 4. Advanced tissue engineering techniques, including the use of scaffolds and stem cell therapies to promote meniscal regeneration and repair.

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AM3101 for Meniscus Tears

Phase 1 & 2

Recruiting

Led By Brian M Grawe, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial tests AM3101, a treatment for knee injuries, on patients with meniscal tears needing repair. It aims to help the knee tissue heal better after surgery, reducing complications.

Who is the study for?

This trial is for men and women aged 18-40 with MRI evidence of a meniscus tear, either alone or with an ACL tear. Participants must have a BMI ≤ 40 kg/m2, normal liver and kidney function, and be able to follow the study's procedures. Exclusions include severe arthritis, other ligament injuries requiring surgery (except ACL), recent drug/alcohol dependence, current statin use or allergy to simvastatin.

What is being tested?

The trial tests AM3101 against a saline placebo in aiding meniscal repair after injury. It's designed as a double-blinded study where neither participants nor researchers know who receives the real treatment versus the placebo until after results are collected.

What are the potential side effects?

While specific side effects of AM3101 aren't listed here, common ones from similar treatments may include injection site reactions like pain or swelling, potential allergic reactions to ingredients in the formula, and general discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Healing Assessed via MRI

Incidence of Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treated with repair and AM3101Experimental Treatment1 Intervention

Syringe containing AM3101 for injection.

Group II: Treated with repair and 0.9% sodium chloride (saline)Placebo Group1 Intervention

Syringe containing commercially available 0.9% sodium chloride for injection.

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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

Common treatments for meniscus tears include surgical options like arthroscopic partial meniscectomy, which removes the damaged portion of the meniscus to alleviate pain and improve joint function. Non-surgical treatments often involve physical therapy to strengthen the muscles around the knee and enhance joint stability. Emerging treatments, such as those being studied in the AM3101 trial, focus on facilitating meniscal repair and reducing non-healing complications through biological agents that promote tissue regeneration. Understanding these mechanisms is important for patients as it helps them weigh the benefits of symptom relief and functional improvement against the risks of non-healing and potential further joint damage.