This study evaluates the effectiveness of GelrinC in the treatment of cartilage damage in the knee. GelrinC is a synthetic material called PEG-DA combined with a natural protein called fibrinogen. Together, these materials form an implant which is inserted into the ?hole? in your cartilage. As time goes on, new tissue forms around the implant and the implant gradually degrades so that eventually only the new tissue remains. This study hopes to find that the new tissue closely resembles your natural cartilage tissue, like the hole was never there in the first place.
Some patients with holes in their cartilage undergo a procedure called a microfracture, which stimulates the bone marrow within your knee bones to start the healing process. In this study, patients will have a microfracture procedure done with the additional implantation of the GelrinC. We will compare the results of the patients who received GelrinC to previous patients who only had the microfracture procedure. In an earlier clinical research study, GelrinC was shown to be safe for use and showed improvement in pain levels after surgery, symptoms and ability to do day to day activities.
Patients participating in the study answer questionnaires about their symptoms and functionality. Patients also undergo 4 MRI scans to evaluate how the knee is healing over the course of 5 years. There are 10 post-operative visits patients attend: 7 times within the first two years and then yearly at 3, 4 and 5 years.
NeoCart tissue implant for the treatment of articular cartilage injuries in the knee
This is a company-sponsored Phase 3, randomized research study evaluating an investigational treatment called NeoCart?, a tissue implant made from a patient?s own cells, aimed at repairing certain knee cartilage injuries. 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 may be caused by an injury or repetitive motion.
It is a common problem that 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. The purpose of this study is to learn about the safety and potential efficacy of the investigational cartilage tissue implant, NeoCart?, compared to microfracture, the current standard of care surgery for articular cartilage defects of the knee.
Patients who are between 18 and 59 years old and who have symptoms of pain in one knee may be candidates for this study will be screened for study recruitment. Accepted patients will have a two out of three chance of being treated with NeoCart? and a one out of three chance of receiving the microfracture procedure. Patients in each group will know their treatment group, have a specific rehabilitation program, and be evaluated periodically for three years after treatment.
The study sponsor is Histogenics, Corp. For more information, text knee1 to 87888, call (773)257-7057 or visit?www.NeoCartImplant.com.
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