European Regulations and Their Impact on Tissue Banking

Extensive CoE-EU cooperation ensures coherence and complementarities between the principles of the CoE guides which can be regarded as recommendations on best practice, and the technical requirements of the EU directives which set out legally binding requirements. This means that the same standards now exist throughout European continent. Having a common set of standards facilitates cooperation between different healthcare systems, especially in cases of emergencies, and the export–import issues. Adoption of the same quality management and traceability systems helps to minimise the risks and prevent disease transmissions. It reassures patients who undergo treatments outside of their countries. The tissue establishments need to introduce technical and structural changes to adhere to the new regulations which ultimately results in saving and improving of lives of many patients.This and other EU documents on tissues and cells are also available at     

Establishment of the 1st European Tissue Bank and a Vision of the Future of Tissue Banking

The paper offers a short history of the oldest European tissue bank, in cooperation with important international organizations and eduction authorities. The final part details the organization of development in research and clinical use by the bank in the field of human embryonal cells.     

American Association of Tissue Banks: A Historical Reflection Upon Entering the 21st Century

The American Association of Tissue Banks (AATB) is a scientific, not-for-profit, peer-group organization founded in 1976 to facilitate the provision of transplantable tissues of uniform high quality in quantities sufficient to meet national needs. The Association was created well before there was governmental oversight of tissue banking. The organization consists of individuals involved in tissue banking, medical users, and scientists in the field. Current structure consists of a 13-member Board of Governors with specific subgroups including Musculoskeletal, Reproductive, Skin, Tissue Bank Councils and Council of Accredited Tissue Banks. A historical review shows the evolution from development of guidelines to publication of standards, and from an inspection conducted by peers to one conducted by an independent, trained professional inspector. Association growth and historical accomplishments are highlighted.     

Fetal Tissue Banking for Transplantation: Characteristics of the Donor Population and Considerations for Donor and Tissue Screening

We initiated this study to evaluate the suitability for therapeutic use in transplantation of tissues obtained from human abortuses. We have developed protocols for the collection, handling and preservation of hepatic stem cells from electively aborted embryos and have developed methods for assessment of the cells so derived and processed. In this paper we present our findings regarding screening of potential donors, acquisition of fetal tissues, and assessment of the tissues for potentially infectious contaminants. We assess the suitability of the tissue donors according to current standards used for donors of commonly transplanted tissues (e.g., bone grafts, skin grafts and heart valves) and present data regarding the real availability of tissues from elective abortion procedures that would meet those standard tissue banking criteria.We specifically evaluated the donor's willingness to provide a blood sample for testing, conducted a detailed interview similar to those used for typical organ and tissue donors, and assessed the type and incidence of contamination in collected tissues. We find that although many women are willing to consent to use of the tissues for transplantation, attrition from the study for various reasons results in few fetal organs ultimately realistically available for transplantation. Typical reasons for attrition include: unwillingness to have a blood sample drawn or tested, positive serology results, social/medical high risk factors for acquisition of transmissible disease, no identifiable organs available, and unacceptable microbial contamination. Thus, although it might seem that due to the numbers of abortions performed annually, that there would be substantial numbers of suitable tissues available, only a small proportion are truly suitable for transplantation.     

Report of the 17th International Congress of the European Association of Tissue Banks (EATB) held jointly with the 17th Annual Congress of the British Association for Tissue Banking (BATB) including EATB/BATB/American Association of Tissue Banks (AATB) Cardiovascular Symposium

The 17th Annual Meeting of the European Association of Tissue Banks (EATB) was held in Edinburgh in November 2008 together with the British Association for Tissue Banking (BATB) and received excellent evaluation by its participants. The meeting included, for the first time, a cardiovascular symposium co-organised by EATB and BATB together with the American Association of Tissue Banks (AATB). This was a first in terms of collaboration for the three associations. The many professionals involved in organising the meeting created an excellent clinical and scientific programme including regulatory issues and featured, also for the first time three interactive workshops about clinical donor cases, quality management and cardiovascular allografts.     

Gray zones around diffuse large B cell lymphoma. Conclusions based on the workshop of the XIV meeting of the European Association for Hematopathology and the Society of Hematopathology in Bordeaux, France

The term “gray-zone” lymphoma has been used to denote a group of lymphomas with overlapping histological, biological, and clinical features between various types of lymphomas. It has been used in the context of Hodgkin lymphomas (HL) and non-Hodgkin lymphomas (NHL), including classical HL (CHL), and primary mediastinal large B cell lymphoma, cases with overlapping features between nodular lymphocyte predominant Hodgkin lymphoma and T-cell/histiocyte-rich large B cell lymphoma, CHL, and Epstein–Barr-virus-positive lymphoproliferative disorders, and peripheral T cell lymphomas simulating CHL. A second group of gray-zone lymphomas includes B cell NHL with intermediate features between diffuse large B cell lymphoma and classical Burkitt lymphoma. In order to review controversial issues in gray-zone lymphomas, a joint Workshop of the European Association for Hematopathology and the Society for Hematopathology was held in Bordeaux, France, in September 2008. The panel members reviewed and discussed 145 submitted cases and reached consensus diagnoses. This Workshop summary is focused on the most controversial aspects of gray-zone lymphomas and describes the panel’s proposals regarding diagnostic criteria, terminology, and new prognostic and diagnostic parameters.     

Combining Smaller Patch,RV Remodeling and Tissue Regeneration in Pulmonary Valve Replacement Surgery Design May Lead to Better Post-Surgery RV Cardiac Function for Patients with Tetralogy of Fallot

Patients with repaired Tetralogy of Fallot (ToF), a congenital heart defect which includes a ventricular septal defect and severe right ventricular outflow obstruction, account for the majority of cases with late onset right ventricle (RV) failure. The current surgical approach, which includes pulmonary valve replacement/insertion (PVR), has yielded mixed results. A computational parametric study using 7 patient-specific RV/LV models based on cardiac magnetic resonance (CMR) data as "virtual surgery" was performed to investigate the impact of patch size, RV remodeling and tissue regeneration in PVR surgery design on RV cardiac functions. Two patch sizes, three degrees of scar trimming (RV volume shrinkages: 9%, 17%, 25%) and hypothetical use of regenerated myocardium as replacement of patch and scar were considered in these models. Our preliminary results indicate that each of the three techniques (smaller patch, RV remodeling, and myocardium regeneration) had modest improvement on post-PVR RV ejection fraction (from 1.76%-4% over the conventional PVR procedure) and combination of all three techniques had the best performance (a 4.74% improvement in ejection fraction over the conventional PVR, for the patient studied). Changes in RV stress, strain and curvatures were also observed. However, their linkages to RV ejection fraction were less clear. Further investigations are required to confirm our findings.     

Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine

Background

Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy.

American Association of Clinical Endocrinology Disease State Clinical Review: The Clinical Utility of Minimally Invasive Interventional Procedures in the Management of Benign and Malignant Thyroid Lesions

ObjectiveThe objective of this disease state clinical review is to provide clinicians with a summary of the nonsurgical, minimally invasive approaches to managing thyroid nodules/malignancy, including their indications, efficacy, side effects, and outcomes.MethodsA literature search was conducted using PubMed and appropriate key words. Relevant publications on minimally invasive thyroid techniques were used to create this clinical review.ResultsMinimally invasive thyroid techniques are effective and safe when performed by experienced centers. To date, percutaneous ethanol injection therapy is recommended for recurrent benign thyroid cysts. Both ultrasound-guided laser and radiofrequency ablation can be safely used for symptomatic solid nodules, both toxic and nontoxic. Microwave ablation and high-intensity focused ultrasound are newer approaches that need further clinical evaluation. Despite limited data, encouraging results suggest that minimally invasive techniques can also be used in small-size primary and locally recurrent thyroid cancer.ConclusionSurgery and radioiodine treatment remain the conventional and established treatments for nodular goiters. However, the new image-guided minimally invasive approaches appear safe and effective alternatives when used appropriately and by trained professionals to treat symptomatic or enlarging thyroid masses.