Most of the standards for the tissue engineered medical products should be fundamentally different in their characteristics from the conventional de facto standards which have been based on the market perception and/or interchangeability, but be de jure standards which are the constitutional rules or guidelines in order to establish new preferable medical products. Recently, the ISO/TC150/SC7 (International Organization for Standards/ Technical Committee 150 for Surgical Implants/ Sub Committee 7 for Tissue Engineered Medical Products) has been set up in 2007 that was proposed and organized by Japan as international secretariat. In harmonization with the international activities in ISO/TC150/SC7, ISO/TC194/SC1 and ASTM/F04 the Japanese standardization trends have been accelerated rapidly in these years.
The Guided Tissue Regeneration therapy using absorbable / non-absorbable membrane is applied to insurance in April, 2008, and attract attention again. The GC membrane was developed as a bioabsorbable membrane for Guided Tissue Regeneration, and was put on the market as first bioabsorbable product in domestic in 1996. The GC membrane made from a lactic acid-glycolic acid copolymer which is a synthetic polymer has the porus structure, maintaining supply of body fluid, preventing downgrowth of connective tissue. And after healing, GC membrane is absorbed by hydrolysis.
Scaffold is necessary for tooth regeneration. Sponges made from polyvinyl alcohol with formalin cross-linking (PVF sponge) were used as scaffolds for bone formation in vitro and in vivo. Wells of cell culture plates and PVF sponge were coated with dextran to promote bone marrow cell attachment. Calcified tissue was formed conspicuously in wells coated with dextran of 10 kDa at 2 g/dl and of 500 kDa at 4 g/dl with dexametason, in vitro. In vivo bone formation was conspicuously observed in sponges coated by dextran of 10 kDa at 2 g/dl and of 500 kDa at 4 g/dl. Quantity of Ca was 129.20±19.69 µg/scaffold and that of osteocalcin was 25.28±5.71 ng/scaffold. These values suggest that many stem cells would attach in PVF sponge via dextran.