TOSH Participates in Nationwide Study of an Investigational Tissue Implant for Patients with Knee Cartilage Injuries

A total of 245 patients will participate in the study in up to 40 sites across the United States. TOSH is the only institution in Utah participating in the study. 

The objective of the study is to assess the effectiveness and safety of NeoCart^® compared to the current standard of care, microfracture surgery, for certain cases of cartilage injuries in the knee. Microfracture surgery works by creating tiny holes in the bone beneath the injured cartilage, which leads to the formation of blood clots in the affected area that are thought to grow cartilage-building cells. 

“The first two earlier studies for NeoCart met the endpoints for safety, showed improvements in pain and function, and provided enough positive data to perform a more comprehensive Phase III study,” said Tyler Barker, PhD, lead researcher for the study at TOSH. “We can’t say for sure if NeoCart is better than the current standard, but we have seen promising outcomes so far with the previous studies.” 

The study will look at damage to the knee’s hyaline articular cartilage, the smooth, white tissue that covers the ends of bones where they come together to form joints. Damage to this cartilage is usually caused by an injury or repetitive motion, which results in pain and symptoms such as swelling, locking of the knee, and loss of knee function. 

Damaged hyaline cartilage has limited capacity to repair or restore itself. Left untreated, the damage may progressively worsen and may lead to chronic conditions such as osteoarthritis. 

In order to perform the NeoCart procedure, surgeons will first obtain a sample of healthy cartilage from the patient’s knee. The small sample will be treated and placed under special conditions in the laboratory that allow for cell growth. These cells will be used to form a hyaline-like cartilage tissue implant in the shape of a small disc. The implant will then be returned to the surgeon for surgical implantation into the patient’s’ injury site in the knee. 

TOSH orthopedic surgeons, Roy H. Trawick, MD, and Michael C. Holmstrom, MD, will perform the procedures at TOSH. 

“For TOSH to be selected as a participating site in this study shows our standing as one of the nation’s premier organizations for orthopedic care,” said Dr. Barker. “We’re helping advance scientific innovation to offer patients here and across the nation the best possible care.” 

Criteria for the study. Research coordinators at TOSH will consider interested patients from Drs. Trawick’s and Holmstrom’s practices who are between the ages of 18 and 55 years old, suffering from knee pain, and have been told that microfracture surgery is a treatment option. Those who have previously failed other treatments or those who smoke more than one pack of cigarettes per week may not be eligible. Researchers will randomly assign all eligible patients the investigational treatment, NeoCart^®, or the standard of care, microfracture surgery. Eligible patients have a two out of three (67 percent) chance of receiving NeoCart and a one out of three (33 percent) chance of receiving microfracture surgery for their knee cartilage injury. Each patient and the surgeon will know which treatment has been assigned after the patient has been randomized to the study. 

People with pain in one knee who are interested in participating in the study can get more information by contacting Vanessa Henricksen, clinical research coordinator at TOSH at (801) 314-4956 or at Vanessa.Henriksen@imail.org. They can also contact the NeoCart Contact Center at 1.855.963.6227 or NeoCartContactCenter@UBC.com. 

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