2015 ISAKOS Biennial Congress ePoster #1625

In Vivo Feasibility Study of Cross-Linked Atelocollagen Based Meniscus Substitute with a Porcine Defect Model

Ken Nakata, MD, PhD, Suita, Osaka JAPAN
Keisuke Kita, MD, PhD, Osaka, Osaka JAPAN
Tatsuo Mae, MD, PhD, Suita, Osaka JAPAN
Yasukazu Yonetani, MD, PhD, Hirakata, Osaka JAPAN
Tomohiko Matsuo, MD, PhD, Hirakata, Osaka JAPAN
Yuta Tachibana, MD, PhD, Sakai, Asia JAPAN
Hideki Yoshikawa, MD, PhD, Suita, Osaka JAPAN
Shuji Horibe, MD, PhD, Habikino, Osaka JAPAN
Konsei Shino, MD, PhD, Osaka, Osaka JAPAN

Osaka University, Suita, Osaka, JAPAN

The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use: atelocollagen Mighty, Device

Summary: This animal study demonstrated for the first time that atelocollagen based-meniscus substitute was safe and effective for the filling to the porcine knee meniscus defect from the macroscopical and microscopical point of views at the three months after the implantation.

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Abstract:

Knee meniscus play crucial roles in shock absorption, load distribution, lubrication, and joint stability of a knee joint. Although it is well known that meniscus dysfunction leads to knee OA which is one of socio-medical problems not only in the elderly but also in active young or middle-aged people, treatment for a defect in menisci remains to be solved. Atelocollange which includes type I and type III collagen and is made by removal of telo-peptide from bovine skin collagen to reduce immunogenicity has been used in clinical purpose for more than 10 years. We had developed mechanically strengthened sponge-like biomaterial from atelocollagen gel by lyophilized and cross-linked. This material has inter-connected pores so that three dimensional culture were maintained for more than 30 days under a cyclic mechanical loading after human meniscus cell seeding. The purpose of this study was to elucidate the feasibility of this material for meniscus defect using a porcine defect model.

Materials And Methods

Eighteen critical meniscus defects in both legs in nine miniature pigs were evaluated three months after implantation. A 5 mm in diameter cylindrical deficit was created in the anterior segment of medial menisci and were implanted with the cross-linked Atelocollange-based meniscus substitute by a press-fit manner. Positive controls were implanted by an autogenous fibrin-clot and negative controls were remained in defect. After three months implantation, menisci, articular cartilage, and whole knee joint were macroscopically evaluated and pathological sections stained with a Hematoxyline-Eosin staining were also examined for safety and effectiveness using the numerical scale according to Ishida (Tissue Eng 2007).

Results

Macroscopically, there was no adverse effects such as infection, adhesion, or arthritis in the knee joints of Atelocollagen. Microscopic examination revealed that atelocollagen based meniscus substitutes were infiltrated by fibrous vascular tissue from the surrounding synovium and the meniscus body surrounding the . Average safety scale of the Atelocollagen group was 3.67 (± 0.52, S.D.) and this was not significantly different from that of positive nor negative control group. Average effectiveness of the atelocollagen group was 6.5 (± 0.84, S.D.) and this was statistically significantly higher than that of positive or negative control group.

Discussion

This animal study demonstrated for the first time that atelocollagen based-meniscus substitute was safe and effective for the filling to the porcine knee meniscus defect from the macroscopical and microscopical point of views at the three months after the implantation. These results prompt the clinical study in human is feasible.