ProChon Biotech announces expansion of BioCart Cartilage Regeneration System study

Dec 15 2009

ProChon Biotech, Ltd., an innovator of tissue regenerative technologies that are being developed to relieve pain and restore the mobility and quality of life for sufferers of articular cartilage injuries, today announced a significant expansion of its clinical study of the BioCart^™ Cartilage Regeneration System. The randomized, double-arm, open-label, multicenter Phase II study comparing the safety and efficacy of the BioCart^™ System to microfracture for the treatment of symptomatic cartilage defects. ProChon will have ten clinical study sites in the US and Israel by end of this year.

“The expansion of the BioCart^™ clinical program represents an important step towards validating the potential of this promising technology,” said Patrick O’Donnell, chief executive officer of ProChon. “We believe that the BioCart^™ technology addresses some of the major limitations associated with microfracture procedures as well as current generation autologous cartilage cell transplantation technologies. We look forward to working with our esteemed clinical investigators and furthering this important clinical trial.”

“Several patients have been enrolled at our facility and I am extremely encouraged with the results to date,” said Dr. James Gladstone, associate professor of orthopaedics at Mt. Sinai School of Medicine in New York City and an investigator in the clinical study. “Orthopedic surgeons have long sought a safe, long-term solution for regenerating cartilage injuries with real articular cartilage rather than the fibrous cartilage generated by the microfracture procedure. The BioCart^™ System is exciting technology as it harnesses the patient’s own resources to help restore their quality-of-life.”

"The BioCart^™ System is a tremendously promising technology for healing articular cartilage defects," said Dr. Michael A. Mont, director of the Center for Joint Preservation and Reconstruction at the Rubin Institute of Advanced Orthopedics at Sinai Hospital in Baltimore, MD and investigator in the study. "The potential of BioCart^™ System to out-perform microfracture, while allowing for short term recovery and longer lasting effects, may result in a change in the way we treat cartilage injuries.”

Microfracture 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 bores 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.

In contrast, the BioCart™ System is a second-generation cartilage transplantation technology that utilizes novel Chondrocyte Preservation Technology^™ (CPT). CPT incorporates ProChon’s proprietary Fibroblast Growth Factor (FGF2v) solution to grow high quality cells as well as a bio-scaffold technology to house and deliver the cells. FGF is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage.

The BioCart^™ process begins with a small sample of healthy cartilage removed arthroscopically from a non-weight-bearing area of the patient’s knee and then sent to ProChon’s laboratories. Scientists then separate the cartilage cells from the biopsy and introduce them to the first phase of the CPT process. This process greatly accelerates the growth of high-quality articular cartilage cells and will predictably complete the cell expansion within 10 to 14 days as compared to processes that traditionally take four to eight weeks to complete.

After approximately two weeks, the necessary number of cartilage cells are obtained and then seeded in the novel biological scaffold, which is the second phase of the CPT process. The cells are uniformly distributed throughout the scaffold, simulating the architecture of native articular cartilage. The scaffold provides a unique environment that inhibits the cells’ ability to expand, yet permits the cells to deposit the appropriate Extra-Cellular Matrix (ECM) throughout the injury site. The ECM that the cells produce is primarily Type II collagen—the primary component of native cartilage.

When the seeding is complete, the BioCart^™ implant is delivered to the hospital 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 and placed into the lesion area. In approximately six weeks, the knee should be full weight bearing and the patient able to walk normally.