John Noble, Jr., MD, orthopaedic surgeon at the Center for Orthopaedics, has been named principal investigator in a phase II FDA clinical trial. The study compares the safety and efficacy of the BioCart™ Cartilage Regeneration System to microfracture for the treatment of symptomatic cartilage defects and injuries in the knee. Orthopaedic surgeons Dr. Geoffrey Collins and Dr. Steven Hale, also with Center for Orthopaedics, will be Sub-Investigators in the trial as well. The study is currently being undertaken at six sites around the country.
There are two types of cartilage within the knee: articular cartilage meniscal cartilage. This study deals only with articular cartilage. Articular cartilage defects have been notoriously difficult to treat. These can lead to persistent pain despite an otherwise normal knee. Cartilage replacement techniques of been around for about 10 years but have not been found to be superior to a technique called microfracture.
"Orthopedic surgeons have long sought a safe, long-term solution for regenerating cartilage injuries with real articular cartilage," said Dr. Noble. "The BioCart System harvests healthy cartilage cells from the patient, which are then grown in the lab, combined with a novel and natural scaffold, and implanted to facilitate the regeneration of healthy cartilage. This technology is very exciting as it uses the patient's own tissue in combination with new and innovative technology to provide better results than an artificial implant alone. We're basically harnessing the body's ability to heal itself."
Dr. Noble is seeking patients between the ages of 16 and 60 who have a single contained cartilage lesion (a chip in the articular cartilage) that was caused principally by acute trauma - such as a fall or sports injury. If the injury was previously treated with microfracture, the patient must be at least two years removed from a previous microfracture treatment. Eligible participants will undergo either a microfracture procedure or treatment with the BioCart System. They will be followed regularly for 12 months post-procedure, with additional follow-ups at intervals of 24 and 60 months. For additional information on this study, please call 337-312-8405 or go to www.prochon.com.
The BioCart System, developed by ProChon Biotech, utilizes a proprietary growth factor to accelerate the growth of high-quality articular cartilage-producing cells. A small sample of healthy cartilage is removed arthroscopically from a non-weight-bearing surface of the patient's knee and is sent to ProChon's laboratory. Scientists then separate the cartilage producing cells from the sample and grow these cells in a special solution of the patient's own serum and enhanced with the growth factor. After approximately two weeks, the necessary number of cells are obtained and seeded into a unique biological scaffold. The BioCart implant is then returned to the surgeon for implantation in the patient's knee. As part of the minimally invasive procedure, the implant is custom cut to precisely fill the injured site. In approximately six weeks, the knee is expected to be full weight bearing and the patient able to walk normally.
In contrast, microfracture, often used to treat these types of injuries, allows the body's own bone marrow stem cells to "fill-in" a defect, producing a scar tissue patch. This effectively repairs the damaged site and aids in protecting the adjacent cartilage from progressive damage. The surgeon creates small holes into the bone underneath the damaged cartilage in order to allow blood and marrow healing elements into the area of missing cartilage. However, while scar tissue, called fibrocartilage, fills the area where the cartilage is missing, it does not have the same strength and resiliency as normal articular cartilage. Fibrocartilage does not usually stand up over time and typically wears down after a few years, and may require a repeat procedure. Rehabilitation is a lengthy process, often taking up to a year to achieve full mobility.
"We are very excited about the potential of BioCart," says Dr. Noble. "Our goal at Center for Orthopaedics is to bring new advances in care to our patients, and this study is one more way we are doing just that."