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Biobanking of turkey ovarian tissue appears to be the most cost-effective method for the long-term preservation of female genetics. However, to ensure the successful transplantation of biobanked ovarian tissue for breed or line revival, the transplantation and development of fresh ovarian tissue must be evaluated. To assess transplantability, ovaries from poults 1 to 15 days posthatch (dph) were cultured in ovo in chicken eggs for 6 d and compared with the equivalent fresh tissue. The viability of cultured ovarian tissue was evaluated visually, whereas the level of late-stage apoptosis was measured via the TUNEL assay. In addition, the diameter and density of prefollicular germ cells and follicles (primordial and primary) were measured to assess maturation. Results showed that all cultured grafts (74/74), on surviving chicken chorioallantoic membrane, were viable with low levels (0.8 ± 0.1%) of late-stage apoptosis. The diameter of prefollicular germ cells in cultured ovaries from poults at 5 and 7 dph were larger (P < 0.002) than that of their preculture counterparts but were not able to reach their in vivo size. No significant follicular growth was observed in ovaries cultured in ovo; however, prefollicular germ cell density was over 4-fold greater in ovaries cultured from 7 dph poults (81,030 ± 17,611/mm 3 ) than in their in vivo counterpart (16,463 ± 6,805/mm 3 ). Interestingly, cultured ovaries from all other ages displayed equal or lower (P ≤ 0.05) prefollicular germ cell densities than their in vivo counterparts. Cultured ovaries from poults at 5 and 7 dph also exhibited an increase (P ≤ 0.05) in follicle density compared with their preculture counterparts; whereas, cultured ovaries from 15 dph poults had decreased densities (P < 0.001) compared with their preculture counterparts. This study demonstrated that, although age of ovarian tissue cultured in ovo did not affect the overall viability, 7 dph ovaries appeared to have a better cellular morphology after culturing in ovo than other ages. In addition, we also demonstrated for the first time that avian follicles can form during tissue culturing in ovo., (Copyright © 2020. Published by Elsevier Inc.)

Objective: To investigate the effectiveness of the reconstruction of posterior cruciate ligament (PCL) with platelet rich plasma (PRP) and 3-strand peroneal longus tendons under arthroscope., Methods: Between June 2014 and December 2017, 58 patients with PCL rupture were randomly divided into two groups: the trial group (PRP assisted reconstruction of 3-strand peroneal longus tendons) and the control group (4-strand hamstring tendon reconstruction alone), 29 cases in each group. There was no significant difference in gender, age, injury side, Kellgren-Lawrence grade, time from injury to operation, and preoperative American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, International Knee Documentation Committee (IKDC) score, Lysholm score between the two groups ( P >0.05). Before operation, at 3 months and 12 months after operation, the IKDC score and Lysholm score of the two groups were recorded to evaluate the knee joint function, AOFAS ankle-hindfoot score was used to evaluate ankle function; KT-2000 examination (knee flexion of 90°, 30 lbs) was used to evaluate the difference of bilateral knee joint posterior relaxation at 12 months after operation, and MRI was used to evaluate ligament reconstruction; CT was used to evaluate the bone tunnel expansion of femur and tibia at 3 months and 12 months after operation., Results: The operation was completed successfully in both groups, there was no complication in the donor tendon area. All the incisions healed by first intention. All the patients were followed up for more than 1 year. The follow-up time of the trial group was 13-17 months, with an average of 15.0 months; that of the control group was 15-20 months, with an average of 15.4 months. At 3 and 12 months after operation, there was no significant difference in AOFAS ankle-hindfoot score when compared with preoperative score and between the two groups ( P >0.05). At 3 and 12 months after operation, the IKDC score and Lysholm score of the two groups were significantly improved, and further improvement was found at 12 months when compared with at 3 months ( P <0.05); the scores in the trial group were significantly better than those of the control group ( P <0.05). At 12 months after operation, the difference of the posterior relaxation of the bilateral knees in the trial group was less than 5 mm in 27 cases, 6-10 mm in 2 cases; in the control group was less than 5 mm in 20 cases, 6-10 mm in 6 cases, and >10 mm in 3 cases; the difference between the two groups was not significant ( Z =0.606, P =0.544). At 12 months after operation, MRI of knee joint showed that all patients had good PCL graft. The MRI score of the trial group was better than that of the control group ( t =2.425, P =0.019). CT examination at 3 and 12 months after operation showed that the bone tunnel expansion of femur and tibia in the trial group were significantly better than those in the control group ( P <0.05)., Conclusion: PRP combined with 3-stand peroneal longus tendons can significantly improve the function and stability of knee joint, effectively promote graft remodeling, and promote tendon bone healing, reduce the expansion of bone tunnel. The effectiveness is satisfactory.

Objective: To compare half-thickness tragal cartilage graft with temporalis fascia graft in terms of graft take-up and acoustic outcomes in type-I tympanoplasty., Methods: The randomised control trial was conducted at Lady Reading Hospital, Peshawar, Pakistan, from January to December 2017, and comprised patients aged 16-60 years undergoing tympanoplasty. The patients were divided into two equal groups using systemic random sampling method. In Group A, tympanoplasty type-I was done using half-thickness tragal cartilage graft, while in Group B, it was done using temporalis fascia graft. Data was analysed using SPSS20., Results: Of the 40 patients, there were 20(50%) in each of the two groups. Overall, there were 24(50%) males and 16(40%) females. The mean age of Group A was 28.57±8.00 years, and in Group B it was 27.14±6.18 years. The graft success rate in Group A was 19(95%) and in Group B it was 18(90%) (p>0.05)., Conclusion: The graft success rates for half-thickness tragal cartilage and temporalis fascia were statistically non-significant.

Organ transplantation is the gold standard for treating end-stage organ diseases, many of whom are on waiting lists. The reasons for this include the nonavailability of suitable organs to be transplanted. In many nations, most of these challenges have been surmounted by the adoption of deceased donor program, which is not so in sub-Saharan countries such as Nigeria. This study is to audit the potentially transplantable organs available from potential deceased donors from a Nigerian tertiary hospital. This is a study of deaths in the intensive care unit (ICU) and the accident and emergency units of the University of Ilorin Teaching Hospital, Nigeria. Data included the biodata, social history, diagnosis or indications for admission, time of arrival and death, causes of death, associated comorbidities, potential organs available, social history, and availability of relations at the time of death. There were 104 deaths in the ICU and 10 patients in the accident and emergency unit. There were 66 males (57.9%) and 48 females (42.1%). Eighty patients were Muslims (70.2%) and 34 were Christians (19.8%). A total of 33 participants were unmarried (28.9%),whereas 81 (71.1%) were married. The tribes of the patients were Yoruba (105, 92.1%), Igbo (7, 6.1%), Hausa (1, 0.9%), and Nupe (1, 0.9%). The age range was 0.08-85 years. Twenty-two (19.3%) had primary and the remaining had at least secondary education. The causes of death were myriad, and there were relatives available at the times of all deaths. The Maastricht classification of the deaths were Class I - 1 (0.9%), Class II - 37 (32.2%), Class III - 9 (7.8%), Class IV - 20 (17.4%), and Class V - 47(40.9%). There were no transplantable organs in 42 (36.5%), one organ in eight (7%), two organs in two (7%), three organs in one (0.9%), four organs in 13 (11.3%), five organs in six (5.2%), six organs in 11 (9.6%), seven organs in 11 (9.6%), eight organs in five (13%), and nine organs in five (4.3%). Deceased donor sources of organs are worthy of being exploited to improve organ transplantation in Nigeria.

Background: Transplantation of kidneys from donation after cardiocirculatory death (DCD) donors is becoming an ever-increasing reality. So far, biopsy histologic assessment is the main parameter for evaluation of graft suitability, but it has several drawbacks and has poor reliability. The aim of this study is to verify if real-time renal resistance (RR) measurement during hypothermic machine perfusion (HMP) can be used as a reliable parameter to evaluate the quality of grafts from DCD and extracorporeal membrane oxygenation (ECMO) donors., Methods: From January 2015 to September 2018, HMP has been systematically applied to all organs from DCD and ECMO donors. All grafts underwent preimplantation biopsy histologic assessment with Karpinski's score. Single kidney transplants (SKTs) or double kidney transplants (DKTs) were performed according to biopsy score results. Kidneys were considered suitable for transplant if RR reached ≤ 1.0 within 3 hours of perfusion. RR trend and postoperative outcome were analyzed considering biopsy score and donor type., Results: A total of 30 kidneys (15 from DCD and 15 from ECMO donors) were used to perform 26 transplants (22 SKTs and 4 DKTs). Considering RR trend, all grafts were considered suitable for transplant within 1 hour of perfusion. Biopsy confirmed this result in all cases, and median score was 3 (range, 0-7). SKT score kidneys had lower starting RR than DKT ones (1.88 vs 2.88; P = .04) but identical final RR (0.58 vs 0.57; P = .76). DKT recipients had faster postoperative creatinine reduction than SKT recipients but similar postoperative day 30 value (1.42 vs 1.15 mg/dL; P = .20). No differences were found between DCD and ECMO grafts in terms of RR trend and postoperative outcome., Conclusions: HMP can be an alternative to histologic biopsy assessment for evaluation of transplant suitability of DCD and ECMO kidneys. If acceptability threshold is reached, SKT can be performed in all cases. ECMO donors should be considered like DCD donors., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The availability of solid organs for transplantation remains low and there is a substantial need for methods to preserve the viability of grafted tissues. Suppression of solid-organ transplant rejection has traditionally focused on highly effective T cell inhibitors that block host immune lymphocyte responses. However, persistent and destructive innate and acquired immune reactions remain difficult to treat, causing late graft loss. Pretreatment of grafts to reduce organ rejection provides an alternate strategy. Approaches using antithrombotics, stem cells, genetic modifications, modulation of infrastructural components (connective tissue, CT; glycocalyx) of donor organs, and engineering of new organs are under investigation. We discuss here new approaches to modify transplanted organs prior to engraftment as a method to reduce rejection, focusing on the CT matrix., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Advanced preservation injury (PI) after intestinal transplantation has deleterious short- and long-term effects and constitutes a major research topic. Logistics and costs favor rodent studies, whereas clinical translation mandates studies in larger animals or using human material. Despite diverging reports, no direct comparison between the development of intestinal PI in rats, pigs, and humans is available. We compared the development of PI in rat, porcine, and human intestines. Intestinal procurement and cold storage (CS) using histidine-tryptophan-ketoglutarate solution was performed in rats, pigs, and humans. Tissue samples were obtained after 8, 14, and 24 h of CS), and PI was assessed morphologically and at the molecular level (cleaved caspase-3, zonula occludens, claudin-3 and 4, tricellulin, occludin, cytokeratin-8) using immunohistochemistry and Western blot. Intestinal PI developed slower in pigs compared to rats and humans. Tissue injury and apoptosis were significantly higher in rats. Tight junction proteins showed quantitative and qualitative changes differing between species. Significant interspecies differences exist between rats, pigs, and humans regarding intestinal PI progression at tissue and molecular levels. These differences should be taken into account both with regards to study design and the interpretation of findings when relating them to the clinical setting.

Introduction: Prior to transplantation, the transplant team is responsible for transplant education and posttransplant expectations. The majority of outcomes research focuses on 1- and 3-year graft survival, with a lack of literature focused upon whether patients have a realistic understanding of how many years deceased donor kidneys can be expected to function after transplant., Objective: To determine whether potential kidney transplant patients' expectations for how long a deceased donor kidney will function after transplantation differs from transplant surgeons, using quantitative analysis., Design: A cross-sectional survey was used with potential adult kidney transplant recipients and transplant surgeons. Patient surveys included demographics, quality-of-life questions, and questions of expectations of kidney function for deceased donor kidneys from the Kidney Donor Profile Index. The survey categorized donor organ risk as 0% to 20%, 21% to 85%, and 86% to 100%, and results were compared to responses from US Transplant Surgeons. Surgeons were contacted via e-mail using an online survey program., Results: Responses included 154 transplant surgeons and 172 patients. Surgeon and patient responses were compared using Fisher exact test, showing a significant difference in each of the donor organ categories. We found that 47% of patient respondents did not correctly interpret the Kidney Donor Profile Index continuum., Conclusion: In every organ donor category, patients had a significantly different expectation for how long a transplanted kidney will last after transplant when compared to transplant surgeons. More study is required to determine why 47% of patients did not correctly interpret the Kidney Donor Profile continuum.

Background: In 2012, the Health Resources and Services Administration and the United Network for Organ Sharing launched the "Electronic Tracking and Transportation" (ETT) project, in response to "labeling and packaging issues" being a frequently reported safety incident. This article describes an improvement project conducted as part of this United Network for Organ Sharing project., Methods: An interdisciplinary team conducted a Process Failure Modes and Effects Analysis, laboratory simulations of organ labeling during procurement, and a heuristic evaluation of a label software application to inform the design of TransNet, a system that uses barcode technology at the point of organ recovery. A total of 42 clinicians and staff from 10 organ procurement organizations and 2 transplant centers in the United States participated. Processes Addressed: Key features of the redesigned labeling system include independent, double entry of label information into the software application, a machine-readable barcode on each organ's label, and a handheld printer for at "point of use" label printing., Outcomes: The new labeling system, TransNet, has become mandatory since June 2017. A survey conducted on early adopters (N = 11), after 1 year of use, indicates the process is safer and more efficient., Implications for Practice: The findings from this study suggest that the application of quality planning methods, common in other industries, when redesigning a health-care process, are valuable and revelatory and should be adopted more extensively. Future evaluation of TransNet effectiveness to reduce safety incidents is critical.

Amendments to India's Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

Under the auspices of the IAEA tissue banking programme on "Radiation Sterilisation of Tissue Graft" conducted from 1985 to 2004, many scientists and surgeons were involved in various regional research and development (R&D) projects mainly in dealing with radiation dose selection, radiation effects on human tissues and quality system in radiation sterilisation. New findings on radiation effects, tissue processing and preservation were shared during the regional and interregional meetings and workshops. Many tissue banks started to use radiation (25 kGy) to sterilize tissue grafts for tissue safety and efficacy and still continue to use it. The IAEA Code of Practice for Radiation Sterilization of Tissues Allografts developed in 2007 offered simpler methods to conduct radiation dose setting and dose validation experiments for tissue grafts. Advances in dose selection and dose mapping are continued under the quality management system when banks need to be certified to continue their operation. The combination of good tissue processing and preservation as well as good radiation practice will ensure the tissue products are properly sterilised thus safe and of high quality. Experience in meeting challenges in using radiation sterilisation and achievements reported by the tissue bankers are shared here.

Background & Aims: Primary non-function and ischaemic cholangiopathy are the most feared complications following donation-after-circulatory-death (DCD) liver transplantation. The aim of this study was to design a new score on risk assessment in liver-transplantation DCD based on donor-and-recipient parameters., Methods: Using the UK national DCD database, a risk analysis was performed in adult recipients of DCD liver grafts in the UK between 2000 and 2015 (n = 1,153). A new risk score was calculated (UK DCD Risk Score) on the basis of a regression analysis. This is validated using the United Network for Organ Sharing database (n = 1,617) and our own DCD liver-transplant database (n = 315). Finally, the new score was compared with two other available prediction systems: the DCD risk scores from the University of California, Los Angeles and King's College Hospital, London., Results: The following seven strongest predictors of DCD graft survival were identified: functional donor warm ischaemia, cold ischaemia, recipient model for end-stage liver disease, recipient age, donor age, previous orthotopic liver transplantation, and donor body mass index. A combination of these risk factors (UK DCD risk model) stratified the best recipients in terms of graft survival in the entire UK DCD database, as well as in the United Network for Organ Sharing and in our own DCD population. Importantly, the UK DCD Risk Score significantly predicted graft loss caused by primary non-function or ischaemic cholangiopathy in the futile group (>10 score points). The new prediction model demonstrated a better C statistic of 0.79 compared to the two other available systems (0.71 and 0.64, respectively)., Conclusions: The UK DCD Risk Score is a reliable tool to detect high-risk and futile combinations of donor-and-recipient factors in DCD liver transplantation. It is simple to use and offers a great potential for making better decisions on which DCD graft should be rejected or may benefit from functional assessment and further optimization by machine perfusion., Lay Summary: In this study, we provide a new prediction model for graft loss in donation-after-circulatory-death (DCD) liver transplantation. Based on UK national data, the new UK DCD Risk Score involves the following seven clinically relevant risk factors: donor age, donor body mass index, functional donor warm ischaemia, cold storage, recipient age, recipient laboratory model for end-stage liver disease, and retransplantation. Three risk classes were defined: low risk (0-5 points), high risk (6-10 points), and futile (>10 points). This new model stratified best in terms of graft survival compared to other available models. Futile combinations (>10 points) achieved an only very limited 1- and 5-year graft survival of 37% and less than 20%, respectively. In contrast, an excellent graft survival has been shown in low-risk combinations (≤5 points). The new model is easy to calculate at the time of liver acceptance. It may help to decide which risk combination will benefit from additional graft treatment, or which DCD liver should be declined for a certain recipient., (Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background: The new kidney allocation system (KAS) intends to allocate the top 20% of kidneys to younger recipients with longer life expectancy. We hypothesized that the new KAS would lead to greater allocation of Public Health Service (PHS) increased-risk donor organs to younger recipients., Methods: Analyses of the Organ Procurement and Transplantation Network data of patients who underwent primary deceased kidney transplantation were performed in pre- and post-KAS periods., Results: The allocation of PHS increased-risk kidney allografts in various age groups changed significantly after implementation of the new KAS, with an increased proportion of younger individuals receiving increased-risk kidneys (7% vs 10% in age group 20-29 y and 13% vs 18% in age group 30-39 y before and after KAS, respectively; P < .0001). This trend was reversed in recipients 50-59 years old, with 31% in the pre-KAS period compared with 26% after KAS (P < .0001)., Conclusions: The new KAS resulted in a substantial increase in allocation of PHS increased-risk kidneys to candidates in younger age groups. Because increased-risk kidneys are generally underutilized, future efforts to optimize the utilization of these organs should target younger recipients and their providers., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose of Review: The coronary artery bypass graft (CABG) operation is one of the few remaining operations/interventions on diseased arteries that are not routinely verified during or immediately after the procedure. This review answers the 'how', 'when' and 'why' of intraoperative CABG assessment., Recent Findings: More recent than new literature on this topic, is the increased interest in quality assurance of CABG. This is most likely due to reports in the last 5 years suggesting CABG superiority to percutaneous coronary intervention (PCI) for improved mid-term and long-term outcomes; for example, for patients with diabetes mellitus (Freedom Trial by Farkouh in 2012), and for patients with SYNTAX score ≥ 33 (SYNTAX Trial by Mohr in 2013). Possibly CABG is re-emerging from the era-of-better-and-better-stents and is now deemed worthy of improvement., Summary: In order to fully compliment PCI, the operative major adverse cardiac event rate of CABG must rival that of PCI. In order to reduce technical errors, it is best practice to perform intra-operative assessment of bypasses, especially since we have the tools.

Objectives: Surgeons needing human cardiovascular tissue for implantation in their patients are confronted with cardiovascular tissue banks that use different methods to identify and decontaminate micro-organisms. To elucidate these differences, we compared the quality of processing methods in 20 tissue banks and 1 reference laboratory. We did this to validate the results for accepting or rejecting tissue. We included the decontamination methods used and the influence of antibiotic cocktails and residues with results and controls. The minor details of the processes were not included., Methods: To compare the outcomes of microbiological testing and decontamination methods of heart valve allografts in cardiovascular tissue banks, an international quality round was organized. Twenty cardiovascular tissue banks participated in this quality round. The quality round method was validated first and consisted of sending purposely contaminated human heart valve tissue samples with known micro-organisms to the participants. The participants identified the micro-organisms using their local decontamination methods., Results: Seventeen of the 20 participants correctly identified the micro-organisms; if these samples were heart valves to be released for implantation, 3 of the 20 participants would have decided to accept their result for release. Decontamination was shown not to be effective in 13 tissue banks because of growth of the organisms after decontamination. Articles in the literature revealed that antibiotics are effective at 36°C and not, or less so, at 2-8°C. The decontamination procedure, if it is validated, will ensure that the tissue contains no known micro-organisms., Conclusions: This study demonstrates that the quality round method of sending contaminated tissues and assessing the results of the microbiological cultures is an effective way of validating the processes of tissue banks. Only when harmonization, based on validated methods, has been achieved, will surgeons be able to fully rely on the methods used and have confidence in the consistent sterility of the tissue grafts. Tissue banks should validate their methods so that all stakeholders can trust the outcomes., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

There is no consensus on the allocation of renal transplants from expanded criteria donors (ECD). The Kidney Donor Profile Index (KDPI) is used without the need for pretransplant donor biopsies (PTDB). We explored whether PTDB based on Remuzzi Score (RS) allows identification of those marginal kidneys in the highest calculated KDPI risk group (>91%) that appropriate for single transplantation. A retrospective study was conducted of 485 consecutive kidneys procured from a single center and transplanted if the RS was ≤4. We compared 5-year kidney and patients survival between KDPI groups and between RS <4 or =4 in the highest KDPI group. The median KDPI (interquartile range) was 71 (66-76) for KDPI <80% (n = 77), 86 (81-90) for KDPI 81-90% (n = 82), and 97 (94-100) for KDPI >91% (n = 205). Patient survival at 5 years was 85.7%, 85.3%, and 76.09% (P = 0.058) and death-censored graft survival was 84.4%, 86.5%, 73.6% (P = 0.015), respectively for each KDPI group. In >91% calculated KDPI group, there were no differences in graft survival depending on the RS (<4 vs. =4) (P = 0.714). The implementation of PTDB based on RS used for allocation of organs with the highest KDPI range could support to the acceptance of suitable organs for single transplantation with good patient and graft survival rate., (© 2017 Steunstichting ESOT.)

This study aimed to investigate the protective effects of EGb761, a Ginkgo Biloba extract, against brain death-induced kidney injury. Sixty male Sprague Dawley rats were randomly divided into six groups: sham, brain-death (BD), BD + EGb b48h (48 hours before BD), BD + EGb 2 h (2 hours after BD), BD + EGb 1 h, and BD + EGb 0.5 h. Six hours after BD, serum sample and kidney tissues were collected for analyses. The levels of blood urea nitrogen (BUN) and serum creatinine significantly elevated in the BD group than in sham group. In all the EGb761-treated BD animals except for the BD + Gb 2 h group, the levels of BUN and serum creatinine significantly reduced (all P < 0.01). EGb761 attenuated tubular injury and lowered the histological score. In addition, the longer duration of drug treatment was, the better protective efficacy could be observed. EGb761 significantly reduced IL-1β, IL-6, TNF-α, MCP-1, IP-10 mRNA expression and macrophage infiltration in the kidney. EGb761 treatment at 48 hour before brain death significantly attenuate the levels of p-JNK-MAPK, p-p38-MAPK, and p-STAT3 proteins (all P < 0.05, compared to BD group). In summary, our data showed that EGb761 treatment protected donor kidney from BD-induced damages by blocking SAPK and JAK-STAT signalings. Early administration of EGb761 can provide better protective efficacy.

As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient's use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.

Background: A shortage of donors poses a serious problem for organ transplantation around the world. In response, the concept of the expanded criteria donor (ECD) has been defined to include donors with traditionally less favorable characteristics. That definition has now been accepted and is being applied in kidney transplantation in the United States and Europe. However, the ECD has not yet been defined for deceased donor kidney transplantation in Japan., Patients and Methods: We analyzed data on graft survival and relevant risk factors in patients who received deceased donor kidney transplants through the East Japan Branch of the Japan Organ Transplant network (n = 1051). Recipients were divided into two groups: the standard-function group (estimated glomerular filtration rate [eGFR] ≥20 mL/min/1.73 m 2 ; n = 906) and the poor-function group (eGFR <20 mL/min/1.73 m 2 ; n = 145; Cox proportional hazards regression analysis; P < .0001)., Results: The 10-year survival rate was significantly lower in the poor-function group than in the standard-function group (85.5% vs 22.5%; P < .0001). The two groups differed significantly in recipient and donor risk for graft failure. Recipient risk factors were length of time on dialysis before renal transplantation and incidence of acute rejection after transplantation. Donor risk factors were donor category (heart death), age, history of hypertension, presence of cerebrovascular disease, mean urine output, and donor creatinine level immediately before donor nephrectomy, total ischemic time, and warm ischemic time., Conclusion: Data from deceased donor transplantation should be analyzed in depth to determine which factors influence renal function after transplantation. In addition, ECD standards should be reconsidered for use in a Japanese context., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Methodology: We determined the content of amide I, amide III, PO4, CO3, and CH2 in samples of fresh bone, bone frozen at -80°C thawed once, bone after two freeze-thaw cycles, and chemically cleaned bone chips. A total of 750 Raman spectra were collected per sample group and the derived quantitative values compared statistically by one-way ANOVA., Results: We found statistically significant differences between the investigated sample groups differing in their treatment already after one freeze-thaw cycle and as well after multiple freeze-thaw cycles, and/or chemical cleaning. Chemical cleaning decreased the content of all measured components compared to the fresh sample as detected by Raman spectroscopy. We further used the derived data to calculate the mineral to matrix ratios for each sample group., Discussion: Our data indicate that significant changes of the chemical quality and mineral to matrix ratio occur during freeze-thawing and chemical cleaning. At the same time, this study highlights the importance of sampling and testing at multiple locations for reliable predictions of the chemical composition. We think that it is very desirable to test the quality of bone graft material before transfer to a recipient; this might ultimately help define parameters to choose the best graft for the patient. It is also important to highlight that this is a preliminary study, which shows the importance of detecting changes in the chemical quality of bone grafts before transfer to the patient.

Comparisons of hematopoietic stem cell transplantation (HSCT) methods in retrospective studies are often hampered by the heterogeneity of comparison groups. The refined disease risk index (DRI) is a potentially interesting tool to compare HSCT protocols as it is based on the disease type and burden at transplant and stratifies patients into four prognostic groups for overall survival (OS). We included 265 patients with partial T-cell-depleted graft (TDEP) and 163 non-TDEP patients in a retrospective study and compared outcomes following stratification using the refined DRI. The 2-year OS rate for TDEP patients was 81.6, 60.9 and 43.3% for the low-, intermediate- and high-risk groups, respectively (P<0.001). For non-TDEP patients, the 2-year OS rate was 62.9, 48.8, 44.2 and 7.6% for the low-, intermediate-, high- and very-high-risk groups, respectively (P<0.001). There was no significant difference when comparing OS between TDEP and non-TDEP for the low-, intermediate- and high-risk groups, but TDEP patients had less acute GvHD grades II-IV. In conclusion, we confirm that the refined DRI is a valuable tool to compare the outcomes of different HSCT protocols. We demonstrate also that TDEP did not impact on the outcome of HSCT, but it did reduce the incidence of acute GvHD.

Background: Optimizing vascular access outcomes is still a challenge, since 30-60% of arteriovenous fistulas fail or do not mature and catheters are widely used in contemporary patients., Methods: This study reports on strategies and outcomes in a single center in which access planning, surgery and maintenance are managed by a team of nephrologists. We retrospectively analyzed 305 fistulas and 61 grafts created in 270 consecutive patients between 2002 and 2013., Results: The percentage of patients receiving a fistula or graft who initiated hemodialysis with a mature access was 68.6%. Among prevalent patients, 71.7% used a fistula, 15.7% a graft and 12.6% a catheter. Rates of primary failure and revision before cannulation were 14.4 and 1.6% for fistulas vs. 4.9 and 3.3% for grafts. After maturation, complications (1.040 vs. 0.188 per patient-year (py)) and interventions (0.743 vs. 0.066 per py) were greater for grafts than for fistulas (p < 0.001). Secondary patency did not significantly differ between grafts and fistulas (median survival 34.8 vs. 57.3 months, p = 0.36), unless primary failures were excluded from Kaplan-Meier analysis (median survival 34.9 vs. 70.9 months, p = 0.03)., Conclusions: High fistula prevalence, low access-related morbidity and catheter dependence were achieved using individualized strategies, including mid-forearm or perforating vein fistula creation and selective graft placement in high risk patients. Direct involvement of nephrologists throughout all steps of access care can improve access outcomes, by promoting a patient-centered approach., (© 2016 S. Karger AG, Basel.)

Objectives: Organ donations continue to fall, failing to meet the clinical requirements for heart transplantation. Furthermore, the pathophysiology of brain stem death including hormonal and inflammatory changes may lead to significant donor heart injury. Early donor management may potentially alleviate these changes and therefore increase the number of available hearts for transplantation. We aimed to investigate whether early management of borderline donors can increase the heart retrieval rate., Methods: Between September 2011 and February 2013, we performed early donor management of 26 potential heart donors in the intensive care units of the respective donor hospitals. At the time of referral donors were considered as borderline based on high-dose inotrope requirements, history of hypertension and cardiopulmonary resuscitation. Our management protocol included insertion of a pulmonary artery catheter and performance of cardiac output studies, weaning noradrenaline and commencing arginine vasopressin, and administration of tri-iodothyronine, methylprednisolone and insulin. Our primary end-point was donor heart acceptance, depending collectively on the results of cardiac output studies, cardiac contractility and coronary artery patency at the time of retrieval operation., Results: We retrieved 14 (56%) borderline hearts after donor management (Group A) with a 30-day survival rate of 86%. Twelve (44%) organs were declined due to poor heart function (n=8; 66.7%; P<0.001) and/or palpable coronary artery disease (n=4; 33.3%; P=0.018) (Group B). The mean age of Groups A and B was 42.77 and 47.78 years, respectively (P=0.19). Most of the female donors, i.e. 10 (83%), were declined, and only 4 (27%) were accepted (P=0.005). Majority of patients in both groups (Group A: 71.4%; n=10; and Group B: 66.7%; n=8) were on high-dose noradrenaline (>0.08 μg kg(-1) min(-2)) at the time of donor offer. Group A had a mean cardiac output of 6.29 and 3.09 l/min for Group B (P=0.01). A positive smoking history was present in 28.6% (n=4) and 33.5% (n=4) in Groups A and B, respectively (P=0.793). Cardiopulmonary resuscitation was performed on 3 (21.4%) patients in Group A and 2 (16.7%) in Group B (P=0.759). A history of hypertension was present in 7.1% (n=1) of the Group A and 33.3% (n=4) of the Group B donors., Conclusions: In our study, we were able to retrieve more than half of the potential heart donors as a result of early active donor management without impacting on the post-transplant recipient outcome. Early active donor management may assist in increasing the number of heart transplantations, thus warranting further investigation., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Purpose: The treatment of large or giant cerebral aneurysms by surgical and/or endovascular techniques is difficult and poses relatively high risks. Therefore, a microporous self-expanding (hybrid) stent graft composed of a thin, expandable, segmented polyurethane (SPU) membrane with micropores and a drug-delivery system was developed., Materials and Methods: A commercially available, self-expanding carotid stent was covered with a thin microporous SPU membrane fabricated by the dip-coating method and the excimer laser ablation technique, with an intraluminal coating of argatroban. Experimentally fabricated lateral-wall aneurysms in canine carotid arteries using venous pouches were occluded with the hybrid stent graft (bale-shaped pore density of 23.6%) on one side and a bare-metal stent on the other side without systemic antiplatelet therapy., Results: Angiography at 1, 6, and 12 months of stenting revealed that all arteries were patent without marked stenosis without systemic antiplatelet therapy. All aneurysms treated with hybrid stent grafts remained occluded throughout the 12-month period, while among those treated by bare-metal stents, 2 of 3 aneurysms were occluded at 6 months (67%) and only 1 of 3 aneurysms were occluded at 12 months (33%). Histology revealed that the novel hybrid stent graft had less intimal hyperplasia than the bare-metal stent. The hybrid stent graft was useful for the successful occlusion of these canine carotid aneurysms, even at 12 months., Conclusions: The novel hybrid stent grafts are expected to overcome the disadvantages of fully covered stent grafts and simple bare-metal stents, while combining both their merits, and appear to be useful in the treatment of large or giant cerebral aneurysms., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Issues of preservation of function and the intestinal transplant quality, security for a recipient, prophylaxis of rejection reaction, immunosuppressive therapy were enlighted.

Objectives: Donation after circulatory declaration of death (DCDD) could significantly improve the number of cardiac grafts for transplantation. Graft evaluation is particularly important in the setting of DCDD given that conditions of cardio-circulatory arrest and warm ischaemia differ, leading to variable tissue injury. The aim of this study was to identify, at the time of heart procurement, means to predict contractile recovery following cardioplegic storage and reperfusion using an isolated rat heart model. Identification of reliable approaches to evaluate cardiac grafts is key in the development of protocols for heart transplantation with DCDD., Methods: Hearts isolated from anaesthetized male Wistar rats (n = 34) were exposed to various perfusion protocols. To simulate DCDD conditions, rats were exsanguinated and maintained at 37°C for 15-25 min (warm ischaemia). Isolated hearts were perfused with modified Krebs-Henseleit buffer for 10 min (unloaded), arrested with cardioplegia, stored for 3 h at 4°C and then reperfused for 120 min (unloaded for 60 min, then loaded for 60 min). Left ventricular (LV) function was assessed using an intraventricular micro-tip pressure catheter. Statistical significance was determined using the non-parametric Spearman rho correlation analysis., Results: After 120 min of reperfusion, recovery of LV work measured as developed pressure (DP)-heart rate (HR) product ranged from 0 to 15 ± 6.1 mmHg beats min(-1) 10(-3) following warm ischaemia of 15-25 min. Several haemodynamic parameters measured during early, unloaded perfusion at the time of heart procurement, including HR and the peak systolic pressure-HR product, correlated significantly with contractile recovery after cardioplegic storage and 120 min of reperfusion (P < 0.001). Coronary flow, oxygen consumption and lactate dehydrogenase release also correlated significantly with contractile recovery following cardioplegic storage and 120 min of reperfusion (P < 0.05)., Conclusions: Haemodynamic and biochemical parameters measured at the time of organ procurement could serve as predictive indicators of contractile recovery. We believe that evaluation of graft suitability is feasible prior to transplantation with DCDD, and may, consequently, increase donor heart availability.

Pediatric donor hearts are regularly refused for donor quality with limited evidence as to which donor parameters are predictive of poor outcomes. We compare outcomes of recipients receiving hearts previously refused by other institutions for quality with the outcomes of recipients of primarily offered hearts. Data for recipients aged ≤18 and their donors were obtained. Specific UNOS refusal codes were used to place recipients into refusal and nonrefusal groups; demographics, morbidity and mortality were compared. Kaplan-Meier analysis with log-rank test was used to determine differences in graft survival. A multivariable Cox proportional hazards model was constructed to determine independent risk factors for postoperative mortality. From July 1, 2000 to April 30, 2011, 182 recipients were transplanted and included for analysis. One hundred thirty received a primarily offered heart; 52 received a refused heart. No difference in postoperative complications or graft survival between the two groups (p = 0.190) was found. Prior refusal was not an independent risk factor for recipient mortality. Analysis of this large pediatric cohort examining outcomes with quality-refused hearts shows that in-hospital morbidity and long-term mortality for recipients of quality-refused hearts are no different than recipients of primarily offered hearts, suggesting that donor hearts previously refused for quality are not necessarily unsuitable for transplant and often show excellent outcomes., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant SurgeonsWiley Periodicals, Inc.)

Purpose of Review: Follow-up data from donors following cardiac death (DCD) liver transplants suggest an increased risk of graft failure and morbid complications, and the risk increased with grafts from marginal donors. Donor warm ischaemia (dWIT) stands out as the common aetiological factor. Aim of this review is to examine if super-rapid technique had developed sufficiently enough to improve the effects of dWIT that had been started since treatment withdrawal in category III DCD marginal donors., Recent Findings: The recent findings suggest limited evolvement, but these have not been contributed to reduce dWIT significantly. Evidence suggests hypoperfusion and circulatory stop occurring well before electrophysical inactivity; hence, dWIT is probably underestimated. Time spent since cardiac death to aortic cross clamp is directly linked to ischaemic complications; limited modifications to surgical technique alone have failed to make an impact on these complications. Marginal grafts generally perform worse, increasing the overall financial cost of patient management., Summary: Irrespective of the speed at which aortic perfusion is instituted, the technical developments have not been able to improve outcomes/utility of marginal DCD grafts. The future of the DCD programmes should explore the means of reviving organ damage incurred during dWIT that are incorporated to the super-rapid technique of organ harvest.

Purpose of Review: To underscore the advantages of hypothermic machine perfusion (HMP) in light of the recent discoveries., Recent Findings: The phase I clinical trial of liver HMP has suggested superiority over static cold storage (SCS) preservation. The liver transplant arena has gained more sophisticated insights into the molecular mechanism and biomechanical understanding behind the benefits of HMP. Its ability to attenuate ischemia-reperfusion injury translates to reduction in ischemia-reperfusion injury with improved early allograft function. HMP has the potential to predict graft function as well as enable resuscitation of grafts from extended criteria donors. Targeted therapeutic interventions via HMP will further contribute to optimal preservation and reconditioning of the allografts., Summary: HMP's advantages do not merely derive from its mechanical forte in maintaining the microvasculature patent. It is also a versatile clinical tool with the ability to deliver metabolic substrates, antioxidants and therapeutic agents to the ex-vivo graft, dilution of waste products generated by inefficient or anaerobic respiration, intraoperative ex-vivo assessment and prediction of the graft's future performance posttransplantation. With demonstrated superiority over SCS, HMP holds promise for expanding the donor pool and becoming the gold standard for liver preservation.

Background: Transplanted nephron mass is an important determinant of long-term allograft survival, but accurate assessment before organ retrieval is challenging. Newer radiologic imaging techniques allow for better determination of total kidney and cortical volumes., Methods: Using volume measurements reconstructed from magnetic resonance or computed tomography imaging from living donor candidates, we characterized total kidney (n=312) and cortical volumes (n=236) according to sex, age, weight, height, body mass index (BMI), and body surface area (BSA)., Results: The mean cortical volume was 204 mL (range 105-355 mL) with no significant differences between left and right cortical volumes. The degree to which existing anthropomorphic surrogates predict nephron mass was quantified, and a diligent attempt was made to derive a better surrogate model for nephron mass. Cortical volumes were strongly associated with sex and BSA, but not with weight, height, or BMI. Four prediction models for cortical volume constructed using combinations of age, sex, race, weight, and height were compared with models including either BSA or BMI., Conclusions: Among existing surrogate measures, BSA was superior to BMI in predicting renal cortical volume. We were able to construct a statistically superior proxy for cortical volume, but whether relevant improvements in predictive accuracy could be gained needs further evaluation in a larger population.

Background: Chronic graft-versus-host disease (cGVHD) is the commonest complication of allogeneic bone marrow and blood stem-cell transplantation, occurring in 50% of all cases and causing late mortality in as many as 25%. There are now about 10 000 patients with cGVHD in Germany, and their number is growing by about 500 each year. cGVHD is a chronic multisystem disease due to impaired tolerance mechanisms. It affects many organs in variable ways, impairing organ function and lowering quality of life., Methods: We present consensus recommendations on the treatment of cGVHD that were developed jointly by the German Working Group on Bone Marrow and Blood Stem-Cell Transplantation, the German and Austrian Societies of Hematology and Oncology, the Swiss Blood Stem-Cell Transplantation Group, and the German-Austrian Working Group on Pediatric Stem-Cell Transplantation. All of the recommendations are based on an evaluation of selected publications., Results: Recommendations are given regarding the diagnostic evaluation of cGVHD, first-line treatment (which has a response rate of 30% to 50%), second-line treatment, and topical immunosuppression. Patients with cGVHD should also receive supportive care including anti-infective prophylaxis, vaccinations, hormone replacement, prevention and treatment of osteoporosis, physiotherapy, rehabilitation, and psychosocial assistance., Conclusion: Patients with cGVHD need multidisciplinary care under the guidance of the transplantation center. The aim of these recommendations is to standardize the treatment of cGVHD and thereby improve patient care.

Background: The disparity between the demand for solid organs and the current supply is a growing problem for patients with end-stage liver disease. To overcome organ shortage, extended criteria donor organs are also accepted for liver transplantation., Aims: We here unprecedentedly report the clinical course of patients receiving livers with markedly elevated liver enzymes., Methods: Between November 2007 and December 2010, 15 donor livers with markedly elevated liver enzymes [median aspartate aminotransferase (AST) 1400 (500-7538) U/l, median alanine aminotransferase (ALT) 1026 (308-9179) U/l] were offered to our transplant centre. Based on elaborate judgment, seven of these donor livers were rejected and eight donor livers were transplanted., Results: All eight transplanted patients showed a liver enzyme peak on the day of surgery (AST 2076 ± 1808 U/l, ALT 1087 ± 833 U/l) and a statistically significant decrease from day 0 to day 7 post-liver transplantation. INR decreased and platelet count increased statistically significantly within 1 week after liver transplantation. The patients were discharged from the hospital 28 ± 11 days after liver transplantation in good clinical condition., Conclusions: These data demonstrate that using donor livers with markedly elevated liver enzymes may be an acceptable option to expand the donor pool. Universal objective parameters for acceptance should be defined in future studies., (© 2011 John Wiley & Sons A/S.)

Background: The widening gap between the numbers of patients on the waiting list for organ transplantation and the insufficient numbers of organ donors results in the use of "critical" donors, so-called marginal donors or extended criteria donors. Data concerning the evaluation of extended criteria donors (ECD) in Switzerland are sparse., Methods: All organ donors in Switzerland between 1.1.1998 and 30.6.2009 have been evaluated for special criteria. ECD were defined on the basis of at least one of seven criteria: six DOPKI criteria (ECD-DOPKI) and/or age ≥60 yr (ECD-Age). Once included in the study, special features, short time follow-up (first 7 days after transplantation) and the cold ischaemia time of all the transplanted organs were evaluated., Results: During the period 1.1.1998 to 30.6.2009, a total of 408 organ donors were classified as ECD, reflecting 39% of all organ donors in this time period. Despite the fact that all organ donors in this study fulfilled at least one inclusion criterion, the number of recipients with satisfactory primary organ function was always higher than the respective number with a negative primary outcome within the first seven days after transplantation. A longer cold ischaemia time was associated with organs showing insufficient primary organ function compared to organs with satisfactory primary function. A relevant causal relationship cannot be investigated on the basis of our limited data. In addition, a longer observation period would be necessary to draw a more precise conclusion., Conclusions: ECD as defined by DOPKI and/or age represent a high proportion of all organ donors in Switzerland but show a remarkably good outcome.

The immediate and long-term results of the operative treatment of 473 patients with lower limbs' critical ischemia were analyzed. The ischemia was caused by vascular damage under the level of Pupart ligament. All patients overcame direct and indirect surgical revascularization procedures. The results of the reconstructive operations depended directly upon the transplant permeability both in early and long-term periods. Thus, the shunt thrombosis by femoral-popliteal bypass above the popliteal joint space was 7.5-10.7%, not depending on the operative technique. Whereas, the shunt thrombosis by femoral-popliteal bypass below the popliteal joint space was 8.5-37.0%, directly depending on the operative technique. The thrombosis frequency after femoral-tibial bypass was in between 28.3-100.0%. The comparative analysis proved obvious advantages of direct and combined revascularisations.

ISBT 128 is the global standard for the identification, labeling and information transfer of human blood, cell, tissue and organ products across international borders and disparate health care systems. The system has been designed and perfected over almost two decades to ensure accuracy, safety and efficiency for the benefit of donors, patients and health care workers worldwide. The use of the ISBT 128 standard has grown steadily since a blood bank in Estonia first implemented it in 1997. Today, more than 3,500 facility identifiers for the use of ISBT 128 have been assigned to organizations in 67 countries on six continents. The standard has been accepted by a variety of international standard setting organizations and government regulators. It is managed by ICCBBA, a not-for-profit organization based in the USA that is governed by an international volunteer board of directors. Members of the Board of Directors represent the fields of practice affected by the standard. Advisory groups comprising international experts guide the ongoing development of the ISBT 128 standard to ensure it continues to meet the needs of its users. While there is a cost associated with the implementation and use of the standard, the clear benefits in terms of improved patient safety and ability to meet regulatory traceability requirements justify the costs.

This short communication describes how some Mexican tissue banks have established their own system for coding and traceability of tissues.

In Malaysia, tissue banking activities began in Universiti Sains Malaysia (USM) Tissue Bank in early 1990s. Since then a few other bone banks have been set up in other government hospitals and institutions. However, these banks are not governed by the national authority. In addition there is no requirement set by the national regulatory authority on coding and traceability for donated human tissues for transplantation. Hence, USM Tissue Bank has taken the initiatives to adopt a system that enables the traceability of tissues between the donor, the processed tissue and the recipient based on other international standards for tissue banks. The traceability trail has been effective and the bank is certified compliance to the international standard ISO 9001:2008.

Cell and tissue banking professionals in North America have long understood the value of labeling their allografts with descriptive names that make them easily recognized. They have also understood that advantages exist in possessing the capability to track them internally and externally to better understand tissue handling from donation through distribution. An added insight that can assist with strategic planning is to know who uses them, how many, and for what purpose or application. Uniquely coding allografts naturally aids tracking in event of recall or the rare need to link them if implicated in an adverse outcome report. These values relate to an ability or inability to sufficiently track specific cell/tissue types throughout the allograft's lifetime. These concepts easily fit into the functions of a Quality Program and promote recipient safety. It is management oversight that drives the direction taken and either optimizes this knowledge or limits it. How concepts related to coding and tracing human cells and tissues for transplantation have evolved in North America, and where they may be headed, are described in this manuscript. Many protocols are in place but they exist in numerous operational silos. Quality Management System concepts should drive decision-making and include considerations for future planning beyond our own professional lifetimes.

This paper describes the development of the ISBT 128 coding and labeling for cellular therapy products. It is published on behalf of the international Cellular Therapy Coding and Labeling Advisory Group (see www.ICCBBA.org ).

Modern transplantation of cells, tissues and organs has been practiced within the last century achieving both life saving and enhancing results. Associated risks have been recognized including infectious disease transmission, malignancy, immune mediated disease and graft failure. This has resulted in establishment of government regulation, professional standard setting and establishment of vigilance and surveillance systems for early detection and prevention and to improve patient safety. The increased transportation of grafts across national boundaries has made traceability difficult and sometimes impossible. Experience during the first Gulf War with mis-identification of blood units coming from multiple countries without standardized coding and labeling has led international organizations to develop standardized nomenclature and coding for blood. Following this example, cell therapy and tissue transplant practitioners have also moved to standardization of coding systems. Establishment of an international coding system has progressed rapidly and implementation for blood has demonstrated multiple advantages. WHO has held two global consultations on human cells and tissues for transplantation, which recognized the global circulation of cells and tissues and growing commercialization and the need for means of coding to identify tissues and cells used in transplantation, are essential for full traceability. There is currently a wide diversity in the identification and coding of tissue and cell products. For tissues, with a few exceptions, product terminology has not been standardized even at the national level. Progress has been made in blood and cell therapies with a slow and steady trend towards implementation of the international code ISBT 128. Across all fields, there are now 3,700 licensed facilities in 66 countries. Efforts are necessary to encourage the introduction of a standardized international coding system for donation identification numbers, such as ISBT 128, for all donated biologic products.

Transplantation has a long history in Iran. Cornea was the first tissue transplantation in 1935. The Central Eye Bank of Iran was established in 1991 and the Iranian Tissue Bank (ITB) in 1994. Now, there are also some private cell and tissue banks in the country, that produce different tissue grafts such as homograft heart valves, musculoskeletal tissues, soft tissues, cartilages, pericardium, amniotic membrane and some cell based products. There is not a separate legislation for tissue transplantation but the legal framework for tissue donation is based on the "Deceased or Brain dead patient organ transplantation" act (passed on April 6, 2000). For tissue banking there is no regulatory oversight by the national health authority. To increase the level of safety and considering the importance of effective traceability, each tissue bank has its own policy and terminology for coding and documentation without any correlation to others. In some cases tissue banks have implemented ISO based standards (i.e., ISO 9001) as a basic quality management system.

Due to their limited availability and compatibility, biological products must be exchanged between medical institutions. In addition to a number of national systems and agreements which strive to implement a unique identification and classification of blood products, the ISBT 128 was developed in 1994, followed by the Eurocode in 1998. In contrast to other coding systems, these both make use of primary identifiers as stipulated by the document ISO/IEC 15418 of the International Organization for Standardization (ISO), and thus provide a unique international code. Due to their flexible data structures, which make use of secondary identifiers, both systems are able to integrate additional biological products and their producers. Tissue and cells also constitute a comparable risk to the recipient as that of blood products in terms of false labeling and the danger of infection. However, in contrast to blood products, the exchange of tissue and cells is much more intensively pursued at the international level. This fact is recognised by Directives 2004/23/EC and 2006/86/EC of the European Union (EU), which demand a standardized coding system for cells and tissue throughout the EU. The 2008 workshop agreement of the European Committee for Standardization (CEN) was unique identification by means of a Key Code consisting of country code corresponding to ISO 3166-1, as well as competent authority and tissue establishment. As agreed at the meeting of the Working Group on the European Coding System for Human Tissues and Cells of the Health and Consumers Directorate-General of the European Commission (DG SANCO) held on 19 May 2010 in Brussels, this Key Code could also be used with existing coding systems to provide unique identification and allow EU traceability of all materials from one donation event. Today Eurocode already uses country codes according to ISO 3166-1, and thus the proposed Key Code can be integrated into the current Eurocode data structure and does not need to be introduced separately. The Eurocode product classification for all products is based on its own unique coding system, which can be accessed over the internet by all users who are not themselves members of Eurocode. In summary, it can be said that the standardized single coding system for tissues and cells requires only unique sections in the data structure such the Key Code to fulfil the requirements of the EU Directive. Thus, various systems currently in place in different EU member states can continue to operate if the Key Code as suggested by the EU is integrated into them. The classification and description of each product characteristic is currently being discussed by the DG SANCO Working Group on the European Coding System for Human Tissues and Cells. Following intensive scrutiny in light of the stipulations laid out in EU Directives 2004/23/EC and 2006/86/EC as well as the CEN/ISSS workshop agreements, the Germany Federal Ministry for Health and organisations representing German tissue establishments under the responsibility of the German Society of Transfusion Medicine and Immunohematology, Working Party "Tissue preparations" proposed in 2009 that Eurocode be adopted for the donor identification and product coding of tissue and cells in Germany. The technical details for implementation have already been completed and are presented in the current article.