Soft Tissue Regeneration Inc. (STR) has begun a randomized and controlled clinical study in Europe for its L-C Ligament device for the reconstruction of a ruptured anterior cruciate ligament (ACL).

The study results will be used to obtain CE Mark approval for commercialization of the L-C Ligament in Europe. The company enrolled and treated the study's first three patients on Sept. 24 at the Isala Klinieken in Zwolle, The Netherlands, by a team led by Kees van Egmond, M.D., (an orthopedic surgeon) and supported by Peter Indelicato, M.D., and Robert Stanton, M.D., both members of the STR Scientific Advisory Board. All three patients were treated successfully, including the two patients who received the L-C Ligament device and one patient who was treated with tendon harvested from the patient’s own hamstring (autologous hamstring tendon).

“The repair of a ruptured ACL typically involves the surgical harvesting of the patient’s own hamstring or patellar tendon tissue, often resulting in pain, donor-site morbidity, impaired function, and additional operating time,” van Egmond said in a news release. “With few options to autograft available, the L-C Ligament may fulfill a significant clinical need for a device that will regenerate a functioning ACL while avoiding the morbidity associated with autograft reconstructions and saving a considerable amount of operating time.”

van Egmond also performed the first-in-man L-C Ligament implant procedure in June 2013, and was the primary investigator of STR’s earlier 15-patient safety and feasibility study.

The L-C Ligament clinical trial is a prospective, multi-center, randomized controlled trial that will compare the L-C Ligament to the hamstring autograft in 60 patients needing a surgical reconstruction for an acute ACL injury. The primary endpoint of the study is the absence of revision surgery for graft failure and the function of the reconstruction as measured by established orthopedic evaluation scores for patients following knee surgery. The trial currently is being conducted in Europe but STR executives hope to implement a larger global trial in the United States and Europe late next year.

“This is a major milestone for Soft Tissue Regeneration and the hundreds of thousands of people who suffer ACL injuries annually requiring surgery,” said Joseph Reilly, CEO and co-founder of STR. “It is another step that will help improve patient outcomes on so many levels. Other European sites are beginning the recruitment process and we expect up to six sites to be recruiting by year end.”

The L-C Ligament is a synthetic bioresorbable scaffold that is designed to stabilize the knee after ACL reconstruction surgery and regenerate the ACL. It is manufactured in a patented and proprietary process utilizing a clinically proven polymer called poly (L-lactic acid), or PLLA. This degradable polymer is widely used in orthopedic implantable devices and breaks down into naturally occurring lactic acid, which also is a byproduct of exercise.

The L-C ligament addresses known risks and morbidity associated with allograft and autograft tissues for ACL reconstruction. In particular, no harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site, the company claims. The L-C Ligament is intended to encourage the regeneration of the patient’s own ligament tissue. To date, results from large-scale animal testing and a European safety study have demonstrated that the L-C Ligament can successfully regenerate a native ligament in the intra-articular space.

The L-C Ligament is an investigational device and is not currently available for treatment or sale in the European Union or United States. It only is available as part of the clinical trial.