AM3101 for Meniscus Tears

Overseen By Kimberly A Hasselfeld, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Cincinnati

Must not be taking: Statins

Disqualifiers: Arthritis, Pregnancy, Drug dependence, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AM3101, to determine if it heals meniscus tears in the knee more effectively than the usual method. Meniscus tears are common knee injuries that cause pain and mobility issues. The study compares two groups: one receiving AM3101 and the other receiving a placebo (a harmless substance resembling the treatment, in this case, saline). Suitable candidates for this trial have an ACL and/or meniscus tear confirmed by an MRI and a BMI of 40 or less. The goal is to discover if AM3101 can ease recovery and reduce complications. As a Phase 1 trial, this research focuses on understanding how AM3101 works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you are currently taking simvastatin or any other statin drugs, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AM3101 is being tested for its potential to heal meniscus tears. Although earlier studies have provided limited safety data, the progression of AM3101 to this testing stage suggests it showed promise in initial safety evaluations. Researchers are closely monitoring how patients respond to the treatment and are vigilant for any side effects.

It is important to note that AM3101 is not yet approved for use, and its safety in humans remains under study. Participants in this trial will be closely monitored by doctors to ensure safety. The trial aims to identify and manage any risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for meniscus tears involve surgery or physical therapy to repair the damaged tissue. However, AM3101 offers a novel approach by using a special injectable compound. Researchers are excited about AM3101 because it targets the healing process directly at the site of injury, potentially accelerating recovery and improving outcomes compared to standard treatments. This targeted therapy could offer a more efficient recovery, minimizing downtime and enhancing tissue repair in a way that traditional methods do not.

What evidence suggests that AM3101 might be an effective treatment for meniscus tears?

Research has shown that AM3101 is designed to help repair tears in the meniscus, a piece of cartilage that cushions the knee joint. Meniscus tears are common injuries. In this trial, some participants will receive AM3101, an injectable treatment that aims to reduce complications when the meniscus doesn't heal properly. Studies suggest that AM3101 could lower the high failure rate of meniscus surgeries, which is about 25%. By helping the meniscus heal better, AM3101 might also prevent further problems like joint inflammation after an injury. Early results are promising, but more research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Brian M Grawe, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

MRI evidence of ACL plus meniscus tear, or isolated meniscus tear

Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions

My liver and kidney tests are normal.

Exclusion Criteria

Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study

Elevated AST or ALT liver enzymes at time of screening

I do not need surgery for ligament injuries other than the ACL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AM3101 or a saline solution following meniscal repair

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI assessments

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AM3101
• Saline Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Treated with repair and AM3101 Experimental Treatment 1 Intervention

Syringe containing AM3101 for injection.

Group II: Treated with repair and 0.9% sodium chloride (saline) Placebo Group 1 Intervention

Syringe containing commercially available 0.9% sodium chloride for injection.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05560477

Study to Evaluate the Safety and Efficacy of AM3101 ... The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing ...

2. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-the-safety-and-efficacy-of-am3101-to-augment-meniscal-healing

Study to Evaluate the Safety and Efficacy of AM3101 to ... The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing ...

3. uc.edu uc.edu/news/articles/2022/08/university-of-cincinnati-researchers-develop-new-treatment-for-common-knee-injury.html

UC researchers develop new treatment for common knee ... AM3101 is an injectable drug being developed as a therapy to reduce the frequency of complications and morbidities associated with failed ...

4. amplicorepharma.com amplicorepharma.com/copy-of-products-1

AM3101 - Meniscus Repair Unfortunately, the failure rate for treatment is close to 25%. Furthermore, if damaged meniscus is left untreated, post-trauma osteoarthritis (PTOA) will ...

5. news-medical.net news-medical.net/news/20230710/New-clinical-trial-seeks-a-regenerative-pharmaceutical-solution-for-meniscal-tears.aspx

New clinical trial seeks a regenerative pharmaceutical ... Researchers at UC have begun a Department of Defense-funded clinical trial that seeks a regenerative pharmaceutical solution for meniscal tears.

6. uc.edu uc.edu/news/articles/2023/07/uc-begins-dod-funded-clinical-trials-with-amplicore.html

UC begins DOD-funded clinical trials with Amplicore Researchers at UC have begun a Department of Defense-funded clinical trial that seeks a regenerative pharmaceutical solution for meniscal tears.

7. synapse.patsnap.com synapse.patsnap.com/drug/519220159a0d4c9e945a292e121d70d7

AM-3101 - Drug Targets, Indications, Patents Much of the meniscus is avascular tissue, and the limited blood supply to this area impedes the healing process, resulting in a surgical failure rate of ~25%.