The liver tissue bank and clinical database in China

To develop a standardized and well-rounded material available for hepatology research,the National Liver Tissue Bank(NLTB)Project began in 2008 in China to make well-characterized and optimally preserved liver tumor tissue and clinical database.From Dec 2008 to Jun 2010,over 3000 individuals have been enrolled as liver tumor donors to the NLTB,including 2317 cases of newly diagnosed hepatocellular carcinoma(HCC)and about 1000 cases of diagnosed benign or malignant liver tumors.The clinical database and sample store can be managed easily and correctly with the data management platform used.We believe that the high-quality samples with detailed information database will become the cornerstone of hepatology research especially in studies exploring the diagnosis and new treatments for HCC and other liver diseases.

Allogenic banking of dental pulp stem cells for innovative therapeutics

Medical research in regenerative medicine and cellbased therapy has brought encouraging perspectives for the use of stem cells in clinical trials. Multiple types of stem cells, from progenitors to pluripotent stem cells, have been investigated. Among these, dental pulp stem cells(DPSCs) are mesenchymal multipotent cells coming from the dental pulp, which is the soft tissue within teeth. They represent an interesting adult stem cell source because they are recovered in large amount in dental pulps with non-invasive techniques compared to other adult stem cell sources. DPSCs can be obtained from discarded teeth, especially wisdom teeth extracted for orthodontic reasons. To shift from promising preclinical results to therapeutic applications to human, DPSCs must be prepared in clinical grade lots and transformed into advanced therapy medicinal products(ATMP). As the production of patient-specific stem cells is costly and time-consuming, allogenic biobanking of clinical grade human leukocyte antigen(HLA)-typed DPSC lines provides efficient innovative therapeutic products. DPSC biobanks represent industrial and therapeutic innovations by using discarded biological tissues(dental pulps) as a source of mesenchymal stem cells to produce and store, in good manufacturing practice(GMP) conditions, DPSC therapeutic batches. In this review, we discuss about the challenges to transfer biological samples from a donor to HLA-typed DPSC therapeutic lots, following regulations, GMP guidelines and ethical principles. We also present some clinical applications, for which there is no efficient therapeutics so far, but that DPSCs-based ATMP could potentially treat.

A Review of Skin Banking Guidelines and Standards Worldwide:Towards the Harmonization of Guidelines for Skin Banking in Therapeutic Applications for the Regions under the Asia Pacific Burn Association(APBA)

Currently,there are no harmonized guidelines which govern skin banking in the Asia Pacific region.Therefore,skin banks are either unregulated or rely on their nation’s legislation or international accreditation to uphold their quality standards.A new set of skin banking guidelines was devel-oped through a comprehensive review and collation of best international practices for the Asia Pacific Burn Association(APBA)members,from donor screening and testing,to skin recovery,processing,storage and distribution,and quality assurance.National regulatory requirements reviewed include the European directives,Australia’s Therapeutic Goods Administration and Sin-gapore’s tissue banking standards.Further technical and quality management recommendations are referenced from the American Association of Tissue Banks(AATB),the United States Food and Drug Administration standards and guidance documents,various relevant European guides,Japanese Society of Tissue Transplantation guidelines and the Asia Pacific Association of Surgical Tissue Banking.Adapted mainly from the AATB standards,the new Asia Pacific Burn Association Guidelines for Skin Banking in Therapeutic Applications offer a comprehensive manual,address-ing:governance and contracts;staff responsibilities;quality management;facilities,equipment and supplies management;donor consent and testing;and recommendations of good practices pertaining to skin recovery,processing,storage and distribution.Besides complementing current generic regulations,they provide technical specifications of major aspects unaddressed in most legislations.This inaugural set of new regional skin banking guidelines would be a start for regional members of the APBA to adopt,and will hopefully culminate in a set of standards so that,in the long run,skin allografts from this region can be of similar quality,which can simplify import process and facilitate the exchange of allografts between members.