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.

Personalising pancreas cancer treatment:When tissue is the issue

The treatment of advanced pancreatic cancer has not moved much beyond single agent gemcitabine until recently when protocols such as FOLFIRINOX(fluorouracil,leucovorin,irinotecan and oxaliplatin)and nab-paclitaxelgemcitabine have demonstrated some improved outcomes.Advances in technology especially in massively parallel genome sequencing has progressed our understanding of the biology of pancreatic cancer especially the candidate signalling pathways that are involved in tumourogenesis and disease course.This has allowed identification of potentially actionable mutations that may be targeted by new biological agents.The heterogeneity of pancreatic cancer makes tumour tissue collection important with the aim of being able to personalise therapies for the individual as opposed to a one size fits all approach to treatment of the condition.This paper reviews the developments in this area of translational research and the ongoing clinical studies that will attempt to move this into the everyday oncology practice.

Hepatitis B transmission by cell and tissue allografts:How safe is safe enough?

More than 2 million human tissue transplants(bone,tendon,cartilage,skin,cornea,amniotic membrane,stem cells,heart valve,blood vessel,etc.),are performed worldwide every year.Cells and tissues are shared between countries which have different regulations and laboratory equipment and represent a risk of hepatitis B virus(HBV)transmission that has become a global safety concern.While the risk of transfusiontransmitted HBV infection from blood donations has been estimated,the rate of HBV transmission from donors to recipients of allografts is unknown and varies between different tissues.There are various important ways of reducing the transmission risk,but donor screening and donor testing are still the main factors for preventing HBV transmission.HBV detection is included in the routine screening tests for cell and tissue donors.The standard test for preventing transplant-transmitted hepatitis B is the hepatitis B surface antigen.The implementation of methods involving nucleic acid amplification and the new generation of reactives to detect viral antibodies or antigens with an immunoassay,has increased the sensitivity and the specificity of the screening tests.The objective of our research was to review the literature and critically analyse the different steps for avoiding HBV transmission in cell and tissue donors,focusing on the screening tests performed.

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.