P-24.1.5 - Novel Meniscal Scaffold Implantation for Irreparable Meniscal Tear Treatment: From Bench to Clinical Trial
Abstract
Purpose
Purpose: The meniscus plays a role in knee load distribution and stabilization. We had shown that polyglycolic acid (PGA) covered with L-lactide-ε-caprolactone copolymer (P(LA/CL)) scaffold was the most effective meniscal defect regeneration in a rabbit model. The purpose of this study was to show the evaluation with meniscal scaffold in a minipig followed for 48 weeks post-implantation and introduce the clinical trial in its first stage.
Methods and Materials
Materials and Methods: The meniscal scaffold was supplied with 50% of strain level and compared with native porcine menisci during biomechanical analysis. Scaffold pieces were incubated in chondrocytes, and the cell viability was evaluated using live/dead assay. Furthermore, 10 mm of meniscus was resected as the defect model in the minipig. PGA scaffold was implanted on the defect and sutured side by side and peripheral rim. Histological analysis was performed till 48 weeks post-scaffold implantation. Finally, arthroscopic implantation has been introduced as the first step of clinical trial.
Results
Results: In vitro, the stress-strain curve of scaffold was comparable with that of native porcine menisci; cells migrated into and were viable in the scaffold. In vivo, the implanted scaffold was covered with the original tissue at 4 weeks and many cells were observed in the implanted scaffold, which was getting absorbed in newly formed tissue. The meniscal shape was preserved after implantation, whereas partial meniscectomy had shrunk at 48 weeks post-implantation (Fig. 1). In the clinical trial, implantation was performed via arthroscopic surgery. The segmented meniscal scaffold was brought to an appropriate position in the knee joint, and rein-type suture was pulled not to push the peripheral side during inside-out suturing (Fig. 2).
Conclusion
Conclusion: The novel meniscal PGA scaffold improved the initial strength and cell viability in vitro, and triggered meniscal regeneration in vivo. The clinical trial was initiated, and introduced a surgical procedure of scaffold implantation.
