2025 ISAKOS Biennial Congress ePoster
Clinical Trial of Artificial Protein (Silk-Elastin) for Augmentation of Arthroscopic Meniscal Repair (Carp-Se Trial)
Masakazu Ishikawa, MD, PhD, Kita-Gun, Kagawa JAPAN
Shunya Tsuji, MD, Hiroshima JAPAN
Naofumi Hashiguchi, MD,MPH, Hiroshima JAPAN
Goki Kamei, MD, PhD, Hiroshima JAPAN
Akinori Nekomoto, MD、PhD, Hiroshima, Hiroshima Prefecture JAPAN
Atsuo Nakamae, MD, PhD, Hiroshima JAPAN
Nobuo Adachi, MD, PhD, Hiroshima JAPAN
Hiroshima University, Hiroshima, Hiroshima, JAPAN
FDA Status Not Applicable
Summary
The study demonstrates that silk-elastin, a novel protein, shows significant promise in enhancing meniscal repair in the avascular zone, offering a potential new treatment option to improve healing and prevent osteoarthritis after meniscal injury.
ePosters will be available shortly before Congress
Abstract
Introduction
Meniscal injuries are a common and important source of knee dysfunction and disability. Due to poor healing potential, especially in avascular zone of the meniscus, partial meniscectomy is recognized as a well-tolerated treatment option. However, meniscectomy has been reported to accelerate the degeneration of articular cartilage, which leads to osteoarthritis of the knee joint. Therefore, “Save the meniscus” is the worldwide slogan and development of a novel treatment method for meniscal repair has been required. Silk-Elastin (SE) is a novel protein by recombinant DNA technology with relevant genes of silkworm fibroin and human elastin. It was reported that SE hydrogels have the potential
to accelerate wound healing in decubitus ulcers of diabetic mice. SE has a high cell affinity and rich elasticity. These biological and mechanical properties of SE will have favorable effect and could be a novel solution for meniscal repair. After obtaining the promising positive results of basic researches in which significant meniscal healings were confirmed, we started the investigator-initiated clinical trials. The purpose of this study is to demonstrate the clinical results of this human trials.
Methods
The single-center, prospective, single-arm, exploratory clinical trial was conducted on eight patients who had meniscal tears in the avascular area. Arthroscopic meniscal repair with administration of SE (P47K-WAS-MR, Figure 1 and 2) was performed in all patients. The primary outcome of this study is to assess the safety and technical feasibility of arthroscopic SE administration. As a secondary outcome, the success of the repair will be evaluated through MR images and a second look arthroscopy conducted three months after the initial surgery. From MRI images, signal change s were diagnosed according to the Mink 3-stage classification, Grade1-3a,b. Grade 3b demonstrates "unhealed". Arthroscopically, we categorized the meniscal healing at three levels: "completely healed”, “incompletely healed”, and “unhealed”.
Results
There were no significant adverse effects after the meniscal repair and P47K-WAS-MR administration. From MR findings five cases demonstrated Grade 2. Four patients’ meniscus were categorized as “completely healed” and the other 4 patients’ meniscus were as “incompletely healed” arthroscopically. There were no patients whose meniscus was categorized as “unhealed” (Figure 3). Although initial time point of evaluation of clinical outcomes was 3 months after surgery, clinical scores such as KOOS score, Lysholm score, IKDC score, and VAS improved after surgery.
Discussion And Conclusion
The results of this clinical study demonstrate that SE has significant positive effects on meniscal repair in avascular zone of torn meniscus in human. This novel approach will be the future option for the promotion of meniscal healing after repair.