Regentis Biomaterials expanded its clinical trial of GelrinC for the treatment of articular knee cartilage damage to 11 U.S. sites.
Here are three things to know:
1. The Sage study is an FDA Investigational Device Exemption clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The phase 3 study will enroll 120 patients at these sites:
- Chicago-based Rush University Medical Center
- Fort Lauderdale (Fla.) Orthopaedic Surgery & Sports Medicine
- San Diego-based Grossmont Orthopaedic Medical Group
- Salisbury, Md.-based Peninsula Orthopaedic Associates
- Gulf Breeze, Fla.-based Andrews Research & Education Foundation
- Morrisville, Vt.-based Mansfield Orthopaedics
- Altoona (Pa.) University Orthopedics Center
- Minneapolis-based TRIA Orthopaedic Center
- The San Antonio Orthopaedics Group
- Savannah, Ga.-based Optim Orthopedics
- Bozeman, Mont.-based Alpine Orthopedics
2. To be eligible for the study, participants must be between 18 and 50 years of age and have pain caused by cartilage damage in only one knee.
3. GelrinC is composed of a polyethylene glycol and a structurally modified form of human fibrinogen. It is designed to be implanted as a liquid so it can completely fill the defect before being cured into a gel, which enables the patients' stem cells to settle on its surface. Within six to 12 months, GelrinC is designed to be resorbed by the body and replaced with new cartilage tissue.
According to Regentis Biomaterials' President and CEO Alastair Clemow, PhD, cartilage repair is "the largest unmet need in orthopedic sports medicine today."