***UPDATE: The NeoCart trial is no longer accepting participants.***
The San Antonio Orthopaedic Group (TSAOG) 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 Brad S. Tolin, M.D. will be leading the clinical trial at The San Antonio Orthopaedic Group. Participating TSAOG surgeons include:
- B. Christian Balldin, M.D.
- S. Josh Bell, M.D.
- Ronald W. Connor, M.D.
- Thomas M. DeBerardino, M.D.
- Frank J. Garcia, M.D.
- Robert U. Hartzler, M.D., M.S.
- Alan E. Hibberd, M.D.
- Bryan W. Kaiser, M.D.
- G. Lane Naugher, M.D.
- Eloy Ochoa, Jr., M.D.
- Richard L. Ursone, M.D.
- Casey D. Taber, M.D.
- Brad S. Tolin, M.D.
- Daniel C. Valdez, M.D.
- Sergio Viroslav, M.D.
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 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.
According to Dr. Tolin, “Neocart potentially represents the exciting next generation of joint cartilage restoration. Knee cartilage injuries can be destructive to the joint surface, as cartilage has very little inherent capability to repair itself. Longer term, this damage can eventually lead to degenerative arthritis. Biologic restoration of the articular cartilage joint surface can potentially avert the destructive progress of arthritis and the associated pain and functional disability.”
Patients who are between 18 to 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 the NeoCart® implant and a one out of three chance of receiving the microfracture procedure, the current standard-of-care for this condition. Patients in each group will have a specific rehabilitation plan and will be evaluated regularly for three years after treatment.
The study sponsor is Histogenics Corporation. For more information, visit www.NeoCartImplant.com, www.clinicaltrials.gov (keyword “NeoCart Phase 3”) or contact The NeoCart Contact Center at (830) 469-4546, text KNEE1 to 87888, or email NeoCartContact@Histogenics.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.