Florida Orthopaedic Associates seeks participants for a research study of a tissue implant for knee cartilage injuries
Florida Orthopaedic Associates 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 Mark W. Hollmann, M.D. will be leading the clinical trial at the Florida Orthopaedic Associates site.
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 who are between 18 to 55 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 the NeoCart® implant 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, visit www.NeoCartImplant.com, www.clinicaltrials.gov (keyword "NeoCart Phase 3") or contact The NeoCart Contact Center at 1.855.9.NEOCART (1.855.963.6227) or NeoCartContactCenter@UBC.com.
NeoCart®, a Phase 3 investigational product is an implant produced using a patient's own cartilage cells. A Phase 1 clinical trial conducted in the United States demonstrated favorable preliminary results, which supported proceeding to a Phase 2 clinical trial. A Phase 2 clinical trial conducted in the United States comparing NeoCart® to the standard-of-care microfracture met its endpoints for safety and for improvement in pain and function. These results support the continued clinical development of NeoCart®. The two-year results of the Phase 2 clinical trial are publicly available (Crawford et al. J Bone Joint Surg Am. 2012;94:979-89). A Phase 3 clinical trial conducted in the United States comparing NeoCart® to the standard-of-care microfracture is currently in progress. Information about the study is available on http://www.NeoCartImplant.com and http://www.clinicaltrials.gov.