A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2B Study To Evaluate The Safety And Efficacy Of Am3101 To Augment Meniscal Healing
Posted Date: Dec 5, 2025
- Investigator: Brian Grawe
- Specialties:
- Type of Study: Drug
This study will look at how well a new medicine, AM3101, works for people who have had meniscus repair surgery in their knee. People in the study will be randomly placed into one of two groups. One group will get an injection of AM3101, and the other group will get a saltwater (placebo) injection. The main goal is to see if AM3101 helps the meniscus heal better. We will check this using an MRI scan 12 months after surgery and compare the results to the placebo group. Another important goal is to make sure AM3101 is safe. We will track any side effects and compare them to the side effects seen in the placebo group. We will also look at how well people can move and use their knee after surgery. We will compare knee function between the AM3101 group and the placebo group. This study will help us learn if AM3101 can make healing better, improve knee function, and be safely used after meniscus repair.
Criteria:
Participants Must Be Male Or Female And Between 18 And 45 Years Old At The Time Of Screening. Participants Must Have Mri Evidence Of Either An Anterior Cruciate Ligament (Acl) Tear Plus A Meniscus Tear, Or An Isolated Meniscus Tear. If A Meniscal Injury Is Present, It Must Be Acute — That Is, The Injury Must Have Occurred Within The Past 6 Months At The Time The Surgery Is Performed. Participants Must Have A Body Mass Index (Bmi) Of 40 Kg/M² Or Less. Liver And Kidney Function Laboratory Panels Must Be Within Normal Ranges At The Time Of Screening. Participants Must Be Willing And Able To Comply With All Study Procedures And The Visit Schedule, And Must Be Capable Of Following Both Oral And Written Instructions. Participants Must Be Willing And Able To Sign An Irb-Approved Informed Consent Form.
Keywords:
Meniscal Repair
For More Information:
Rebekah West
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westrk@ucmail.uc.edu