Results from the award-winning paper were highlighted in a podium presentation during the AOSSM annual meeting. In this study, 43 goats were implanted with the SeriACL Graft and followed over 3, 6 and 12 months; results demonstrated the safety of the device, with initial indications of efficacy in the animal model. The SeriACL Graft, a new biomaterial made from natural silk protein, is installed using a standard surgical procedure to repair a torn ACL and is designed to provide a strong yet temporary support structure that replaces the torn ACL and stabilizes the knee joint.
"This study provides the first evidence of sustainable ACL tissue engineering," said Gregory H. Altman, PhD, President and CEO, Serica Technologies, and senior author of the paper. "Through advances in biomedical engineering, we now have a more thorough understanding of the body's own capacity for ACL healing, if provided the correct impetus. We believe our proprietary technology can provide a long-term bioresorbable graft scaffold that anticipates the defect site's biological and mechanical requirements for ACL regeneration. We are extremely pleased with the results of this study and are aggressively moving forward with our development program, including the initiation of a study with the SeriACL Graft in humans."
Results from this study showed that all animals were weight bearing at 3, 6 and 12 months, with 95% returning to normal gait by 6 months; the majority of knees were clinically stable at all points. Range of motion assessment indicated the knees maintained a normal range flexion and extension at all points. By 12 months, the initial SeriACL graft structure was not evident, indicating the device's ability to provide sufficient direction and space for substantial ligament ingrowth while being bioresorbed. |
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"Current ACL repair options - either an autograft or allograft - each have well-documented, debilitating side effects," said Rebecca Horan, PhD, the study's lead author and Serica's Senior Director of Research and Development. "Our goal with the SeriACL™ Graft is to provide a 'scaffold,' or biomechanical support structure, implanted during a standard surgical procedure, which supports the development of functional ACL tissue, thereby avoiding the limitations and lengthy rehabilitation associated with existing options."
The SeriACL Graft or the surgical procedure did not induce early signs of acute inflammation, swelling or initial scar formation in the goat model, as indicated by rapidly declining scores for pain and knee size.
"The primary focus of our work over the past ten years has been to solve the unmet clinical need in ACL repair, offering surgeons and patients a device that would create the correct environment within the knee to regenerate ACL tissue, while supporting the mechanical structure of the joint during the healing process. Our ultimate goal is for the SeriACL Graft to serve the patient over his or her lifetime," Altman added. "Prior to our study, no one has shown successful 12 month ACL regeneration data in a large-animal model with an off-the-shelf product, due to the demanding mechanical and biological requirements of a functional ACL. We are delighted that the AOSSM has recognized this important work, which brought to bear the combined disciplines of mechanical, biomedical, chemical and textile engineering for the development of our SeriACL Graft."
This study, Clinical, Mechanical and Histopathological Evaluation of a Bioengineered Long-Term Bioresorbable Silk Fibroin Graft in a One Year Goat Study for Development of a Functional Autologous Anterior Cruciate Ligament, was funded by a grant from the National Institutes of Health (NIH) and Serica Technologies, Inc. The very first source of funding which helped to initiate the broader research program began with a $15,000 First Time Investigator Grant from the AOSSM in 1999.
Since 1986, the Cabaud Memorial Award has been presented annually, by the American Orthopedic Society of Sports Medicine, for work that "best exemplifies clinically relevant hypothesis-driven basic science research."
"This award symbolizes what can be accomplished with a strong collaboration between engineers, scientists and surgeons who share a vision to advance medical science and improve patient care," said John C. Richmond, MD, Chair, Department of Orthopedics, New England Baptist Hospital, Boston, MA, and a co-author of the paper. "We are excited by the potential of this device in ACL repair." An acknowledged expert in this area of medicine, Dr. Richmond has conducted more than 5,000 ACL and Rotator Cuff Tendon (RCT) reconstructive surgeries over the past 25 years.
Dr. Altman founded Serica in 1998, after completing his undergraduate and graduate studies at Tufts University, where he ruptured his ACL playing varsity football. His ACL repair surgery was performed by Dr. Richmond. Following knee surgery, Dr. Altman experienced the debilitating side effects of ACL reconstruction. This experience inspired his doctoral work, during which time he developed the concept and technology that became the platform for the current Serica product portfolio under development.
The ACL, one of the four major ligaments of the knee, is the second most commonly injured knee ligament, and is a very common injury among athletes. Female athletes are known to have a higher risk of injuring their ACL. Currently, 200,000 surgeries are performed each year in the U.S. to repair a torn or damaged ACL.
About the Technology
Serica is developing natural silk biomaterials designed to help stabilize soft connective tissue structures - such as ligaments and tendons - following surgical repair. The company's grafts for ACL and rotator cuff tendon repair, as well as its surgical meshes and gels, are comprised of the fiber of the B. mori silkworm. Silk has a proven track record of safety over centuries of human use and Serica's technology seeks to provide predictable and controlled bioresorption by the body, which is a major advantage in many tissue repair and reconstructive surgical procedures.
Serica's biomaterials are intended to act as 'scaffolds' to provide support and relief to damaged tissues, and promote restored function. These implants are designed to allow the natural tissue to heal and resume normal function, as the implant is slowly bioresorbed by the body during the recovery period.
In pre-clinical studies, Serica's 100 percent silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, to facilitate optimal healing. Its products require no re-hydration or advance preparation for surgical implantation.
Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a growth-stage medical device company pioneering silk-based biomaterial platforms for tissue rejuvenation. Incorporated in 1998, Serica's proprietary products currently in preclinical and clinical development are being studied in the areas of orthopedic and sports medicine, aesthetic and reconstructive plastic surgery and other structural tissue repair needs. Serica's team of engineers and scientists are located in a state-of-the-art 22,000-square-foot office, R&D and manufacturing facility in Medford, MA. For more information about Serica Technologies, please visit http://www.sericainc.com/.
Source: Janna Guinen
Spring Communications |
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