Soft Tissue Regeneration, Inc. has enrolled the first patient in 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 patient was implanted at Isala Klinieken in Zwolle, The Netherlands, by a team led by Dr. Kees van Egmond and supervised by Drs. Robert Arciero and Robert Stanton of the United States.
The European 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. A larger, global trial in the United States and Europe is anticipated to begin in 2015.
This patented and proprietary technology was invented by Cato T. Laurencin, M.D., Ph.D. It uses a clinically-proven polymer called poly(L) lactide acid (PLLA), which is derived from renewable sources such as cornstarch. No harvesting of the patient’s tendon is required, thereby eliminating the risks associated with the harvest site.
“Having a scaffold that can stabilize the knee and foster the regeneration of the ligament tissues would constitute a major advancement in the treatment of ACL injuries, ” said Dr. Arciero, who in addition to being one of the attending physicians, is president-elect of the American Orthopaedic Society for Sports Medicine (AOSSM). “This procedure has the potential to facilitate faster, improved healing with very little surgical morbidity for patients.”
Asked what progress the patient should make in the next six months, Joseph Reilly, CEO and co-founder of Soft Tissue Regeneration, told OTW: “The patient left the hospital with no pain and only minor swelling and physical therapy started the first day after surgery. At six weeks the patient is exercising with a stationary cycle. After about three months of exercising on the stationary cycle and when the doctor determines the patient is well enough to start, the patient will begin additional physical therapy exercises for knee extensions and to strengthen the quadriceps muscles. After about six months and when the doctor determines the patient is well enough to start, the patient will also start resistant exercises (Isokinetic) that test and help improve muscular strength and endurance.”
Regarding preparations for the U.S. clinical trial, Reilly commented to OTW, “We have already filed a Pre-Submission package with the FDA and we expect to receive comments before the end of 2013. In the first half of 2014, we will file an IDE [investigational device exemption] with the FDA and expect to receive approval in early 2015, after we submit 12 month data from our EU safety study. During 2014, we meet with several CROs [contract research organizations] and select a firm to work with us in managing our USA clinical trial. In early 2014, we will begin identifying investigators and sites in the USA for our USA clinical trial, which will start in the second half of 2015.”
