04.21.14
Soft Tissue Regeneration Inc. has completed enrollment for a clinical trial of the company’s L-C Ligament, a bioresorbable scaffold for soft tissue regeneration of the anterior cruciate ligament (ACL) of the knee.
The clinical trial is a prospective, multi-center, non-randomized trial to evaluate the safety profile of the L-C Ligament in 15 males and females with acute ACL injuries. The study will measure the rate of revision surgery in treated patients as well as their radio radiographic, clinical, and subjective outcomes.
The trial is being conducted at Isala Klinieken in Zwolle, The Netherlands, by Dr. Kees van Egmond and at Martini Hospital in Groningen, The Netherlands, by Dr. Reinoud Brouwer. A larger, randomized clinical trial in Europe is expected to begin in September.
“The first patient was implanted on June 18, 2013, and is now out more than 10 months,” said Joseph Reilly, president and CEO of Soft Tissue Regeneration. “All 15 patients are doing extremely well and are following a normal course of physical rehabilitation. This is the first step in a process that will help improve patient outcomes on so many levels.”
The L-C Ligament is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery. It is a patented and proprietary technology that uses a clinically-proven polymer called poly(L-lactic acid) (PLLA). This biodegradable polymer is widely used in orthopedic implantable devices and addresses known risks and morbidity associated with allograft and autograft tissues. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site.
“This procedure is straight forward, fast and does not require harvesting of the patient’s tendon, thereby eliminating the risks associated with the harvest site”, said van Egmond, who is the first surgeon in the world to implant the L-C Ligament. “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patients.”
“Patients are reporting a good natural feeling with less swelling and results have been very positive,” noted Brouwer, who completed the last surgery to implant the L-C Ligament.
The L-C Ligament is designed to help regenerate patients' own ligament tissue. To date, results from large-scale animal testing at two years and longer haveshown the L-C Ligament successfully can regenerate a native ligament intra-articularly.
The L-C Ligament is an investigational device and is not available for use or sale in the European Union or the United States. It only is available as part of the clinical trial.
Based in New Haven, Conn., Soft Tissue Regeneration is a clinical stage orthopedic device company developing a tissue engineering platform used to regrow ligaments and tendons.
The clinical trial is a prospective, multi-center, non-randomized trial to evaluate the safety profile of the L-C Ligament in 15 males and females with acute ACL injuries. The study will measure the rate of revision surgery in treated patients as well as their radio radiographic, clinical, and subjective outcomes.
The trial is being conducted at Isala Klinieken in Zwolle, The Netherlands, by Dr. Kees van Egmond and at Martini Hospital in Groningen, The Netherlands, by Dr. Reinoud Brouwer. A larger, randomized clinical trial in Europe is expected to begin in September.
“The first patient was implanted on June 18, 2013, and is now out more than 10 months,” said Joseph Reilly, president and CEO of Soft Tissue Regeneration. “All 15 patients are doing extremely well and are following a normal course of physical rehabilitation. This is the first step in a process that will help improve patient outcomes on so many levels.”
The L-C Ligament is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery. It is a patented and proprietary technology that uses a clinically-proven polymer called poly(L-lactic acid) (PLLA). This biodegradable polymer is widely used in orthopedic implantable devices and addresses known risks and morbidity associated with allograft and autograft tissues. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site.
“This procedure is straight forward, fast and does not require harvesting of the patient’s tendon, thereby eliminating the risks associated with the harvest site”, said van Egmond, who is the first surgeon in the world to implant the L-C Ligament. “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patients.”
“Patients are reporting a good natural feeling with less swelling and results have been very positive,” noted Brouwer, who completed the last surgery to implant the L-C Ligament.
The L-C Ligament is designed to help regenerate patients' own ligament tissue. To date, results from large-scale animal testing at two years and longer haveshown the L-C Ligament successfully can regenerate a native ligament intra-articularly.
The L-C Ligament is an investigational device and is not available for use or sale in the European Union or the United States. It only is available as part of the clinical trial.
Based in New Haven, Conn., Soft Tissue Regeneration is a clinical stage orthopedic device company developing a tissue engineering platform used to regrow ligaments and tendons.