Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Meniscus Tear Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560477
• Other study ID #: Protocol Number: SM17091
• Secondary ID: UC IRB Number: 2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: University of Cincinnati
• Contact: Kimberly A Hasselfeld, MS
• Phone: 513-558-1933
• Email: hasselky[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.

Description:

Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo).

Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo).

Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Male or female = 18 and = 40 years old at time of screening.

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

3. Body mass index (BMI) = 40 kg/m2.

4. Liver and kidney function panels within normal ranges at time of screening

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

6. Willing and able to sign an IRB approved informed consent

Exclusion Criteria:

1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.

2. Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.

3. Have evidence of arthritis = Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.

4. Elevated AST or ALT liver enzymes at time of screening

5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.

6. Known drug or alcohol dependence currently or within the last year.

7. 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.

8. Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.

9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.

10. Known allergic reaction to simvastatin.

11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Drug:
• AM3101
Injectable drug product.
• Saline Placebo
2 mL 0.9% normal saline

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	United States Department of Defense

Country where clinical trial is conducted

United States, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Assessed via MRI	Presence or absence of healing assessed via MRI	12 months
Primary	Incidence of Adverse Events	Incidence of adverse events in subjects receiving AM3101 following meniscal repair, as compared to subjects undergoing meniscal repair and injected with a saline solution (placebo).	12 months

External Links

•   Merck Sharp & Dohme Corp. Approval package for simvastatin (Zocor). 2011
•   US Food and Drug Administration. Nonclinical review for triamcinolone acetonide (Zilretta)
•   US Food and Drug Administration. Retrieved on 02 August 2021from