Preclinical Development of a Novel Medical Device for Total Meniscus Reconstruction
Abstract
The meniscus is an important tissue in the knee; it helps stabilize the joint and protects the cartilage from damage during sports or military activities. Unfortunately, the meniscus is frequently injured, especially in the military where the injury rate is 10 times that of the general population. Injury to the meniscus causes pain and loss of function, and it does not heal on its own. The most common surgical procedure to address these injuries is a meniscectomy, where part or all of the meniscus is surgically removed. This typically provides short-term pain relief, but it can also cause arthritis in the long term. Our team is working on a new, different way to treat severe meniscus injuries. The product is MeniscoFix, an implantable device that is used to completely replace the injured meniscus and allows a new meniscus to form within the implant. Our previous experiments showed that eventually, the MeniscoFix implant resorbs, leaving new meniscus tissue formed by the patient’s own cells. The goal of the present project is to take the next steps forward towards commercialization of this implant so that ultimately it can be used to treat military personnel as well as the general public with severe meniscus injuries. We will develop a repeatable manufacturing process, then complete the safety and performance testing that is required by the U.S. Food and Drug Administration (FDA) before beginning clinical trials in humans. This project addresses the Fiscal Year 2019 Clinical and Rehabilitative Medicine Research Program Focus Area on regenerative medicine and composite tissue engineering. The military benefits are twofold: --In the short term, MeniscoFix has the potential to accelerate the return of Soldiers to active duty after a severe meniscus injury, improving the readiness of the military. --In the long term, MeniscoFix has the potential to prevent the development of arthritis that often happens after a severe meniscus injury, improving the quality of life of the patient and significantly saving on medical costs associated with arthritis, which often leads to total knee replacement surgery. The potential benefits to the general public are similar: more rapid return to daily function, sports, and other activities, and avoiding arthritis associated with severe meniscus injuries. MeniscoFix will help patients who have had severe meniscal injury and/or a previous surgical meniscectomy and are still suffering from knee pain and problems with walking or running. It will help them by essentially growing a new meniscus at the site of the damaged meniscus. There are some risks associated with this and any surgical procedure in the knee, including infection. This research will not result in immediate clinical applicability, but it will take the product development effort several major steps forward towards commercialization. By developing the appropriate manufacturing process, performing the required safety and performance testing, and beginning a dialogue with the FDA, this project will significantly accelerate the MeniscoFix product development effort.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010087
Entities
People
- Michael Dunn
Organizations
- Rutgers University
- United States Army