Seeking participants for a research study of a tissue implant for knee cartilage injuries
CU Sports Medicine is participating in a 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.
A total of 245 patients will participate in the research of the surgical procedure in up to 40 sites across the United States.
Orthopedic surgeon Eric McCarty, MD will be leading the clinical trial at CU Sports Medicine.
The research 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.
To perform the NeoCart® procedure, the surgeon first obtains a sample of healthy cartilage from the patient's knee. The small sample is treated and placed under special conditions in the laboratory that allow for cell growth. These cells are used to form a hyaline-like cartilage tissue implant that is in the shape of a small disc. The implant is then returned to the surgeon for surgical implantation into the patient's' injury site in the knee.
Patients accepted into the study 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 have a specific rehabilitation plan and will be evaluated periodically for three years after treatment.
The study sponsor is Histogenics, Corp. For more information, text knee1 to 87888 or call 1-303-586-2005.
A total of 245 patients will participate in the research of the surgical procedure in up to 40 sites across the United States.
Orthopedic surgeon Eric McCarty, MD will be leading the clinical trial at CU Sports Medicine.
The research 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.
To perform the NeoCart® procedure, the surgeon first obtains a sample of healthy cartilage from the patient's knee. The small sample is treated and placed under special conditions in the laboratory that allow for cell growth. These cells are used to form a hyaline-like cartilage tissue implant that is in the shape of a small disc. The implant is then returned to the surgeon for surgical implantation into the patient's' injury site in the knee.
Criteria
Patients who are between 18 and 59 years old and who have symptoms of knee pain in one knee may be candidates for this study. However, those who have previously failed other treatments or smoke more than one pack of cigarettes per week may not be eligible.Patients accepted into the study 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 have a specific rehabilitation plan and will be evaluated periodically for three years after treatment.
The study sponsor is Histogenics, Corp. For more information, text knee1 to 87888 or call 1-303-586-2005.