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ProChon Biotech, Ltd., is expanding the clinical study of its BioCart cartilage regeneration system. The company plans to have ten clinical study sites in the United States and Israel by end of this year.

The Woburn, Mass.-based firm is developing regenerative tissue technologies to relieve pain and restore the mobility for sufferers of articular cartilage injuries. The study is a randomized, double-arm, open-label, multicenter Phase II trial comparing the safety and efficacy of the BioCart system to microfracture for the treatment of symptomatic cartilage defects.
Microfracture, a current standard of care, 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 often wears down after a few years, and may require a repeat procedure.

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

“The expansion of the BioCart clinical program represents an important step toward validating the potential of this promising technology,” said Patrick O’Donnell, CEO 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.”

According to James Gladstone, MD, associate professor of orthopedics at Mt. Sinai School of Medicine in New York, N.Y., and an investigator in the clinical study, several patients have been enrolled at his facility. He noted that he is “extremely encouraged” with the results to date.

“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,” Gladstone said.