Local Clinical Trial Evaluating New Treatment For Knee Pain

Cartilage damage can be a real pain in the knee. A local clinical trial is looking to relieve that pain with a new implant that may help the body regrow cartilage in the knee, potentially improving quality of life and changing how orthopedic surgeons treat cartilage damage or loss.

Cartilage repair is the largest unmet need in orthopedic sports medicine today, according to Alastair Clemow, Ph.D., president and CEO of Regentis Biomaterials, the company that developed the new implant, known as GelrinC™. Patch sat down with Dr. Clemow to discuss GelrinC and the opportunity for local residents to receive the implant as part of the SAGE clinical study.

Patch: What is the function of knee cartilage and why can it cause people pain?

Dr. Clemow: The knee looks simple from the outside but actually is a complex joint, allowing a wide range of movement in our daily lives. The bottom end of the femur (thigh bone) forms a joint surface with the top end of the tibia (shin bone), both of which are lined with articular cartilage. Cartilage is the most important connective tissue for the normal functioning of the knee joint, allowing the bones to glide easily over each other during movement. When there is substantial damage to the cartilage, it may be difficult for the body’s own cells to heal the damage since cartilage has very little blood supply and does not heal well on its own.

Damage to the cartilage layer can be extremely painful for patients and is usually caused from sudden trauma. Surgery is often required because of the limited capacity for cartilage to repair itself. If left untreated, damaged cartilage can lead to long-term, irreversible joint damage. But, our new investigational knee implant may help dramatically change the lives of patients with damaged cartilage.

Patch: How is cartilage damage currently treated?

Dr. Clemow: Currently, the standard of care is microfracture surgery. During the surgery, small holes are made in the bone underneath the cartilage defect to allow a blood clot to form. The problem with microfracture surgery is that it may result in the formation of fibrocartilage (a weaker type of cartilage), rather than hyaline cartilage (the body’s own cartilage). As a result, unfortunately, this approach often provides only short-term relief and also may require repeated surgeries.

Patch: What is GelrinC and how does it work?

Dr. Clemow: GelrinC is an investigational implant that is being evaluated as a treatment to help the body regrow knee cartilage. GelrinC’s unique mode of action allows it to be implanted as a liquid so that it completely fills the cartilage defect in the knee, and then be cured into a gel that enables the body’s own stem cells to settle on its surface.

Over a period of 6-12 months, GelrinC is gradually absorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function.

Patch: How quickly can patients get back to their day-to-day life?

Dr. Clemow: Patients go home soon after the surgery, which only requires a small incision, and can resume daily activities within 8-10 weeks.

Patch: What is the SAGE Clinical Study?

Dr. Clemow: The SAGE study is a Food and Drug Administration-approved Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. It is a multi-center Phase III pivotal study that will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment.

We are currently or will soon be recruiting patients in 17 cities across the U.S.:

• Altoona, Pennsylvania
• Boston, Massachusetts
• Bozeman, Montana
• Chicago, Illinois
• Denver, Colorado
• Fort Lauderdale, Florida
• Gulf Breeze, Florida
• Minneapolis, Minnesota
• Morrisville, Vermont
• Orange, California
• Orlando, Florida
• Portland, Oregon
• Salisbury, Maryland
• San Diego, California
• San Francisco, California
• Savannah, Georgia
• State College, Pennsylvania

Patch: What criteria do people need to meet to participate in the SAGE Clinical Trial?

Dr. Clemow: Qualified participants include adults between 18 and 50 years of age who have pain in only one knee. There also are additional criteria. People who have knee pain caused by damaged articular damage who would like to be considered for the study can inquire by visiting our website or by calling (833) 430-8686. Everyone who qualifies will receive GelrinC treatment from a board-certified orthopedic surgeon in their area.

This Patch article is sponsored by Regentis Biomaterials

Image Credit: Regentis Biomaterials