BBI Japanese Editor

Japan Tissue Engineering (J-TEC; Gamagori, Japan), which was founded in February 1999, is sponsoring a course on tissue engineering at the department of tissue engineering at Nagoya University School of Medicine (Nagoya, Japan) which began in April. The course, the first research activity at a national university specializing in tissue engineering, is aimed at producing artificial organs using living human cells.

Technologies researched and developed in public or private universities in Japan tend to be less exposed to industry, and thus, some unique application technologies have a less of a chance of being commercialized.

Because of a lack of openness, relationships between universities and companies often have led to fraudulent monetary exchanges which damage sound relationships between universities and companies. Conversely, companies in the private sector in Japan find that forming partnerships with overseas venture companies is more practical and bears quicker results. These companies also find business transactions go more smoothly with overseas companies than dealing with domestic resources. It is difficult to find any company in Japan nowadays – not just major companies but also medium-sized and small companies – that do not have some kind of business relationship with overseas firms. J-TEC's efforts in breaking such a barrier and creating a new relationship with the university should be held in high regard.

J-TEC will pay $200,000 a year for three years to support the course. There is no binding agreement with respect to the results of the research efforts; rather, they are open to other companies and universities as well. The course is led by Professor Minoru Ueda of the department of oral and maxillofacial surgery at Nagoya University School of Medicine, in collaboration with Assistant Professor Kenichiro Hata, also of Nagoya University. The course may contribute to the area becoming a stronghold of artificial organ development in the future; the activities in this thriving area may disseminate technologies nationwide or even worldwide.

The course is based on research into cultured skin involving implantation of epithelial cells from oral mucose, and expands into culturing cartilage and bone. The activities will seek collaborations with organizations both domestically and abroad with respect to tissue culturing and implantation technologies. The objectives of the course include patent search techniques, patent application methods, investigating intellectual property rights and product commercializations. These activities are not unrelated to the Ministry of Education's grand design of transforming national universities into corporations.

Through the Japan Foundation, the course has received an inquiry from the World Health Organization (Geneva, Switzerland) for undertaking treatment of an intractable skin disease known as Buruli ulcer, prevalent in the Republic of Ghana in West Africa. The disease's first outbreak began in 1998, and is prevalent among children under 15. It begins from small eczemas but then spreads throughout the body and eventually destroys skin. The disease is refractory to antibiotics and the treatment requires stripping off of the skin. Amputation may be required in the most dire cases. Buruli ulcer is rampant in West Africa, with prevalence reported in 25 countries in that region.

The treatment is planned by the group led by Ueda, which dispatched Hata to Ghana on Aug. 28 upon obtaining an approval by the ethics committee of Nagoya University. The treatment plan calls for seeding healthy skin tissues harvested from the patient's body and implanting the lesion with cultured skin manufactured by J-TEC. The cultured skin is a thin film grown from a small amount of epithelial cells from extraction of wisdom teeth and are grown into a film in much the same way as growing a plant. The treatment staff will include surgeons from Nagoya University's department of plastic surgery.

Implantations of cultured skin are performed by several hospitals in Japan, with more than 500 clinical cases reported so far, with the cultured skin experimentally grown at participating universities. Nagoya University's department of plastic surgery also has more than 100 clinical cases of cultured skin implantations.

J-TEC, founded last year for manufacturing and marketing of cultured skin and cartilage using culture technologies of human cells and tissues, has begun using cultured skin grown from skin cells harvested from patients. About 10 patients suffering from burns or birthmarks have been treated using the cultured skin under the supervision of Professor Shuhei Torii of the department of plastic surgery at Nagoya University School of Medicine. So far, successful prognosis has been reported for the treated patients. J-TEC will begin clinical trials shortly, with product launch targeted for 2002.

Menicon entering cultured skin business

Menicon (Nagoya, Japan), a contact lens maker, also is entering the cultured skin business, beginning construction of R&D and manufacturing facilities in August, and with operations expected to begin in November, 2001. The company will develop and manufacture cultured skin of both autologous and homologous origin, as well as collagen matrix.

Menicon began research on cultured skin in 1992 and is collaborating with Kitazato University School of Medicine (Sagamihara, Japan) and Aichi Medical University (Aichigun, Japan). A number of other companies are seeking to enter this sector, with expectations for commercializing products within two to three years. One of them, Smith & Nephew Japan (Tokyo), also is conducting a clinical trial in Japan.

The Ministry of Health and Welfare is working on setting up guidelines for commercializing human cells and tissues. The guidelines, which were delayed by questions concerning infection and ethical arguments over using persons' tissues obtained for free, are expected to be announced this fall.

Technologies available from Tsukuba

The Institute of Tsukuba Liaison, a technology licensing organization of the National University of Tsukuba (NUT; Tsukuba, Japan), reported that several medical diagnostic technologies are being offered for joint development by interested companies, domestic or abroad.

One involves diagnostics technology for bronchial asthma. The patent application is titled, "A method of diagnosing bronchial asthma, and the assay-kit." The method, developed by Dr. Yoshiyuki Uchida, assistant professor of the faculty of medicine at NUT, is based on the special immunoassay of a polypeptide stripped off from the intratracheal epithelial cell and dissolved in the sputum of patients with asthma. Using the conventional method, the severity of airway inflammation and airflow limitation in asthma has been only roughly evaluated mechanically by means of maximum flow volume measured with using a peak flow meter. Uchida's diagnostic method not only gives an accurate reading of the degree of disease, but also will make it possible to propose the correct treatment plan with the prediction of a coming spasm.

Another new diagnostic technology, invented by Dr. Hiromasa Kashimura, assistant professor on the same faculty, is titled "A method of detecting Clarithromicin-resistant mutants of Helicobacter pylori, and the primer." Kashimura found three types of mutants that may be the cause of gastric or duodenal ulcers. Each mutant in the gastric juice is easily detected separately by a special DNA assay using specially designed primers combined with fluorescent compounds. (Contact Dr. Junji Seki, licensing advisor of ITL at e-mail: mail@tliaison.com, phone: 81-298-50-0195, or fax: 81-298-58-6072.)

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