Effects of combined strength and endurance training on exercise capacity in kidney transplant cyclists and runners.

INTRODUCTION: After transplantation, engaging in regular physical activity (PA) or sport is recommended for health. Participation to competitive sports is increasingly common among kidney transplant recipients while little is known on how training affects the physical performance in transplanted athletes. AIM: The purpose of this case study was to assess the effects of a tailored training program on exercise parameters in kidney transplant cyclists (CKTRs) and runners (RKTRs). METHODS: Twelve male transplanted athletes were enrolled. The workload at aerobic and anaerobic thresholds, the submaximal aerobic power (V'O2 stage) and rate of perceived exertion (RPE) during an incremental cycling or running test, and the peak instantaneous force (PIF) during a countermovement jump were assessed at baseline (T0) and after 6 months of tailored training (T6) consisting in strength and aerobic exercises. Exercise adherence, blood lipid profile and renal function were also investigated. RESULTS: Eight CKTRs and 4 RKTRs completed the 6-month training period, with a significant increase of training volume (minutes/week). The exercise adherence was met by 90% in both groups. At T6, there were significant (p<0.05) improvements of maximum workload attained, the workload corresponding to the aerobic threshold and PIF, while workloads at anaerobic threshold, V'O2 stage and RPE were unchanged. Blood cholesterol significantly decreased (p<0.01), while the other blood parameters were unchanged. CONCLUSIONS: These findings indicate that the combined strength and endurance training is well tolerated and may improve exercise performance in this selected population of KTRs.

Physical activity and renal function in the Italian kidney transplant population.

BACKGROUND: The well-documented benefits of physical activity (PA) are still poorly characterized in long-term kidney transplant outcome. This study analyzed the impact over a 10-year follow-up of PA on graft function in Italian kidney transplant recipients (KTRs). METHODS: Since 2002, the Italian Transplant-Information-System collected donor and recipient baseline and transplant-related parameters in KTRs. In 2015, 'penchant for PA' (PA ≥ 30-min, 5 times/week) was added. Stable patients aged ≥18 years at the time of first-transplantation were eligible. KTRs with at least 10-year follow-up were also analyzed. Mixed-effect regression models were used to compare eGFR changes over time in active versus non-active patients. RESULTS: PA information was available for 6,055 KTRs (active 51.6%, non-active 48.4%). Lower penchant for PA was found in overweight and obese patients (OR = 0.84; OR = 0.48, respectively), in those with longer dialysis vintage (OR = 0.98 every year of dialysis), and older age at transplant. Male subjects showed greater penchant for PA (OR = 1.25). A slower decline of eGFR over time was observed in active KTRs compared to non-active, and this finding was confirmed in the subgroup with at least 10-year follow-up (n = 2,060). After applying the propensity score matching to reduce confounding factors, mixed-effect regression models corroborated such better long-term trend of graft function preservation in active KTRs. CONCLUSIONS: Penchant for PA is more frequent among male and younger KTRs. Moreover, in our group of Italian KTRs, active patients revealed higher eGFR values and preserved kidney function over time, up to 10-years of follow-up.

Bioelectrical impedance vector analysis (BIVA) in renal transplant recipients during an unsupervised physical exercise program.

BACKGROUND: Muscle weakness, incorrect body water distribution and reduced exercise tolerance are the main characteristics found in renal transplant recipients after surgical treatment. Regular physical supervised exercise programs, at moderate intensity, have been promoted to contrast these aspects, while few data are available for long-term unsupervised mixed exercise plans. Bioelectrical impedance vector analysis (BIVA) provides a semi-quantitative evaluation of body cell mass and body water. This study aims to approach the role of the BIVA analysis in the follow-up of Renal Transplant Group (RTG) and analyze the impact of unsupervised exercise program. METHODS: Thirteen male RTG and ten healthy subjects, adherent to a tailored exercise program, at moderate intensity and prescribed in an unsupervised way, have been followed up for one year. Every six months all the subjects have been submitted to the ergometric test, echocardiographic exam and an analysis of body composition by bioimpedance. They were compared to a healthy control group (HG). RESULTS: A significant reduction of the BMI was observed at the end of the study in the RTG group (T0 24.8±3.2, T12 24.2±3.2 kg/m2; P<0.05). BIVA has shown a lower right quadrant for RTG. All echocardiographic parameters were in a normal range, and no differences were found over time. CONCLUSIONS: Unsupervised tailored and mixed exercise intervention reduces some cardiovascular risks factors. However, it does not modify the frailty of RTG. BIVA analysis seems to have appropriate sensitivity to highlight this aspect.

Longitudinal Analysis of Cardiovascular Risk Factors in Active and Sedentary Kidney Transplant Recipients.

Background: Despite the benefits of physical activity on cardiovascular risk in kidney transplant recipients (KTRs), the long-term effects of exercise have been poorly investigated. This is a three-year observational study comparing graft function and cardiovascular risk factors in active KTRs (AKTRs) vs. sedentary KTRs (SKTRs). Methods: KTRs with stable renal function were assigned to active or sedentary group in relation to the level of daily physical activity based on World Health Organization (WHO) recommendations (<150 or >150 minutes/week, respectively). Complete blood count, renal function indices, lipid profile, blood pressure and anthropometric measures were collected yearly for an observation period of three years. The comparisons between the two groups were performed by repeated measures analyses of covariance (ANCOVAs), with age as a covariate. Results: Fifty-four subjects were included in the study. Thirty of them were identified as AKTRs (M/F 26/4, aged 45 ± 12 years) and 24 as SKTRs (M/F 18/6, aged 51 ± 14 years). Baseline characteristics were similar between the groups except body mass index (BMI) that was significantly higher in SKTRs (p = 0.043). Furthermore, over the three-year observation period, BMI decreased in AKTRs and increased in SKTRs (p = 0.006). Graft function was stable in AKTRs, while it showed a decline over time in SKTRs, as indicated by the rise in serum creatinine levels (p = 0.006) and lower eGFR (p = 0.050). Proteinuria, glucose and uric acid levels displayed a decrease in AKTRs and an increase in SKTRs during the three-year period (p = 0.015, p = 0.004 and p = 0.013, respectively). Finally, concerning lipid profiles, AKTRs had a significant reduction over time of triglycerides levels, which conversely showed a clinically relevant increase in SKTRs (p = 0.014). Conclusions: Our findings indicate that regular weekly exercise training may counteract the increased cardiovascular risks and also prevent graft function decline in KTRs.

Organ donor screening for carbapenem-resistant gram-negative bacteria in Italian intensive care units: the DRIn study.

The 759 cases of brain death declaration (BDD [Italian law, 6 hours of observation time]) that occurred in 190 Italian intensive care units (ICUs) between May and September 2012 were studied to quantify carbapenem-resistant gram-negative bacteria (CR-GN) isolated in organ donors, to evaluate adherence to national screening guidelines, and to identify risk factors for CR-GN isolation. Mandatory blood, bronchoalveolar lavage, and urine cultures were performed on the BDD day in 99% of used donors. Because results were rarely made available before transplant, >20% of transplants were performed before obtaining any microbiological information, and organs from 15 of 22 CR-GN cases were used. Two (lung-liver) of the 37 recipients died, likely because of donor-derived early CR-GN sepsis. ICU stay >3 days (odds ratio [OR] = 7.49, P = .004), fever (OR = 3.11, P = .04), age <60 years (OR = 2.80, P = .06), and positive ICU epidemiology (OR = 8.77, P = .07) were associated with CR-GN isolation. An association between single ICU and risk of CR-GN was observed, as a result of differences across ICUs (ICC = 29%; 95% confidence interval [CI] 6.5%-72%) probably related to inadequate practices of infection control. Continuous education aimed at implementing priority actions, including stewardship programs for a rational use of antimicrobials, is a priority in healthcare systems and transplant networks. Improved awareness among ICU personnel regarding the importance of early CR-GN detection and timely alert systems might facilitate decisions regarding organ suitability and eventually save recipient lives.

Physical Condition, Glycemia, Liver Function, and Quality of Life in Liver Transplant Recipients After a 12-Month Supervised Exercise Program.

BACKGROUND AND AIMS: Despite the excellent long-term outcomes in liver transplant (LT) recipients, several medical complications related to lifestyle still represent an issue. This study examined the effects of a 12-month supervised aerobic and strength training program on the aerobic capacity, muscle strength, metabolic profile, liver function, and quality of life of a cohort of LT recipients. METHODS: LT recipients with stable liver function were assigned to interventional exercise (group A) or usual care (group B). Aerobic capacity, muscle strength, metabolic profile, liver and kidney function, and health-related quality of life were assessed at baseline and after 6 and 12 months. Group A attended supervised training sessions 3 times per week for 12 months. Group B received general recommendations about home-based exercise. RESULTS: Forty patients from 6 Italian LT centers were randomized. Twenty-nine (72.5%, men-to-women ratio 23:6, mean age, 52 ± 8 years) LT recipients completed the study. Baseline characteristics were similar between groups except for body mass index and time from LT. No episode of acute rejection nor increase of transaminases occurred. Maximum workload and body mass index increased in both groups over time, but fasting glucose significantly decreased in group A (94.0 ± 15.0 mg/dL vs 90.0 ± 17.0 mg/dL; P = .037) and increased in controls (95.0 ± 24.0 mg/dL vs 102.0 ± 34.0 mg/dL, P = .04). Upper limb muscle strength increased only in supervised LT recipients. Vitality and general and mental health domains significantly improved after physical exercise. CONCLUSIONS: Supervised combined training was safe and effective in increasing aerobic capacity, muscle strength, and quality of life and in improving glucose metabolism in stable LT recipients.

Promotion of Pre- and Post-Transplant Physical Exercise in the Emilia-Romagna Region: The Network of the Program "Transplantation, Physical Activity, and Sport".

BACKGROUND: Following the positive experience of the national project "A transplant...and now it's time for sport," the Transplant Reference Center of the Emilia-Romagna Region has pursued the promotion of pre- and post-transplant physical exercise by developing a network. METHODS: The path involved the transplant centers and operative units (UU.OO) who wanted to target transplant and waiting list patients, who are clinically stable, to perform personalized exercise through a program (supervised or not) prescribed by a specialist in sports medicine. With the collaboration of the Collective Prevention and Public Health Service, the network was established, consisting of the sports medicine centers and the gyms that promote health for adapted physical activity (PS-AMA). To implement the network, training courses for all the professionals involved (doctors, nurses, exercise specialists) and operational meetings in the transplant centers-nephrology units with patients' associations have been organized. RESULTS: To date, there are 14 transplant centers and UU.OO, 9 sports medicine centers, and 45 PS-AMA involved in this network. Seven training courses were organized with the participation of 193 health professionals. Since January 2016, there have been 65 transplanted patients and 5 patients on the waiting list who practice the prescribed exercise. Of these, 45 carry out supervised exercise in PS-AMA; 25 perform autonomous exercise. Each patient is monitored every 6 months. No problems related to the exercise performance were recorded. CONCLUSIONS: The development of a network of professionals and associations is the key element to raise awareness of physical activity among transplanted and waiting-for-transplant patients, reducing the pathologies associated with a sedentary lifestyle.

Evaluation on the Use of Italian High-Speed Rail to Support Transportation Network for Transplantation Activities.

BACKGROUND: One of the main activities connected with transplantation is the rapid and timely transportation of patients, medical teams, and human organs from donation to transplantation centers under the compliance of national guidelines and principles of quality, performance, and safety. High-speed transportation on a railway network is becoming relevant both in terms of performance and extensiveness of the service. METHODS AND OBJECTIVES: Our study explores the feasibility of adopting a high-speed rail network for the transportation of those organs with large cold ischemia time and those less influenced by transportation-related perturbations (ie, temperature, speed, vibrations), assessing savings and relative performance improvement. In this study, only kidneys have been considered; the transplantation database has been integrated with the national high-speed railway network and timetables. A function is implemented that allocates to air transportations those records with 1 of the 2 ends situated on islands, remote regions, and abroad, while rail transportation is preferred where constraints on capacity and compliance with cold ischemia time are met. Road transportation is still feasible for those records involving 2 adjacent regions and for intraregional transportation. RESULTS: The opportunity of integrated road-rail transportation in place of air or all-road transportation allows users to lower generalized costs and reduce driven distance for personnel and vehicles allocated to a regional transplantation center's fleet and staff. Savings in fleet and staff usage can serve to improve the performances at the local level. CONCLUSIONS: The knowledge and analysis of transportation alternatives for human organs with less stringent safety and preservation criteria allow a more efficient allocation of resources both at the local and national level-without compromising quality and reliability of the system.

A national mandatory-split liver policy: A report from the Italian experience.

To implement split liver transplantation (SLT) a mandatory-split policy has been adopted in Italy since August 2015: donors aged 18-50 years at standard risk are offered for SLT, resulting in a left-lateral segment (LLS) graft for children and an extended-right graft (ERG) for adults. We aim to analyze the impact of the new mandatory-split policy on liver transplantation (LT)-waiting list and SLT outcomes, compared to old allocation policy. Between August 2015 and December 2016 out of 413 potentially "splittable" donors, 252 (61%) were proposed for SLT, of whom 53 (21%) donors were accepted for SLT whereas 101 (40.1%) were excluded because of donor characteristics and 98 (38.9%) for absence of suitable pediatric recipients. The SLT rate augmented from 6% to 8.4%. Children undergoing SLT increased from 49.3% to 65.8% (P = .009) and the pediatric LT-waiting list time dropped (229 [10-2121] vs 80 [12-2503] days [P = .045]). The pediatric (4.5% vs 2.5% [P = .398]) and adult (9.7% to 5.2% [P < .001]) LT-waiting list mortality reduced; SLT outcomes remained stable. Retransplantation (HR = 2.641, P = .035) and recipient weight >20 kg (HR = 5.113, P = .048) in LLS, and ischemic time >8 hours (HR = 2.475, P = .048) in ERG were identified as predictors of graft failure. A national mandatory-split policy maximizes the SLT donor resources, whose selection criteria can be safely expanded, providing favorable impact on the pediatric LT-waiting list and priority for adult sick LT candidates.

How safe are organs from deceased donors with neoplasia? The results of the Italian Transplantation Network.

Guidelines for donor selection have changed to expand the donor pool, considering potential donors affected by a neoplasm. Aim of this retrospective study is to look at the use of organs from donors with a current or history of neoplasm within the Italian Transplant Network. Data, collected and validated by Italian National Health Institute for the time interval 2006-2015, have been reviewed retrospectively by mean of multivariable pivot tables. Donors with neoplasia represented about 5% of all donors, resulting in about 4% of all transplants. Donors presented a benign neoplasm in 29.08% of cases, a malignancy with variable risk of transmission in 69.75% while in 1.34% the nature of neoplasm could not be assessed. Considering all procedures, rate of transmission of a malignancy was 0.03% (10 cases) of all 29858 transplants of the time interval. Notably, cases of transmission were not from donors of this pool, but from donors that, according to our protocols, had no elements of suspect at time of donation. As recipient safety is always the priority and as guidelines have set exclusion criteria for donors with some specific types of malignancy, these results show that use of this type of donors is safe and improve organ pool. Furthermore represent basis for improvement and standardization of donor assessment protocols suggesting that efforts in data collection systems, to produce complete and homogeneous data, are mandatory.

Evolution of Deceased Organ Donation Activity Versus Efficiency Over a 15-year Period: An International Comparison.

BACKGROUND: The donation rate (DR) per million population is not ideal for an efficiency comparison of national deceased organ donation programs. The DR does not account for variabilities in the potential for deceased donation which mainly depends on fatalities from causes leading to brain death. In this study, the donation activity was put into relation to the mortality from selected causes. Based on that metric, this study assesses the efficiency of different donation programs. METHODS: This is a retrospective analysis of 2001 to 2015 deceased organ donation and mortality registry data. Included are 27 Council of Europe countries, as well as the United States. A donor conversion index (DCI) was calculated for assessing donation program efficiency over time and in international comparisons. RESULTS: According to the DCI and of the countries included in the study, Spain, France, and the United States had the most efficient donation programs in 2015. Even though mortality from the selected causes decreased in most countries during the study period, differences in international comparisons persist. This indicates that the potential for deceased organ donation and its conversion into actual donation is far from being similar internationally. CONCLUSIONS: Compared with the DR, the DCI takes into account the potential for deceased organ donation, and therefore is a more accurate metric of performance. National donation programs could optimize performance by identifying the areas where most potential is lost, and by implementing measures to tackle these issues.

Renal function and physical fitness after 12-mo supervised training in kidney transplant recipients.

AIM: To evaluate the effect of a 12-mo supervised aerobic and resistance training, on renal function and exercise capacity compared to usual care recommendations. METHODS: Ninety-nine kidney transplant recipients (KTRs) were assigned to interventional exercise (Group A; n = 52) and a usual care cohort (Group B; n = 47). Blood and urine chemistry, exercise capacity, muscular strength, anthropometric measures and health-related quality of life (HRQoL) were assessed at baseline, and after 6 and 12 mo. Group A underwent a supervised training three times per week for 12 mo. Group B received only general recommendations about home-based physical activities. RESULTS: Eighty-five KTRs completed the study (Group A, n = 44; Group B, n = 41). After 12 mo, renal function remained stable in both groups. Group A significantly increased maximum workload (+13 W, P = 0.0003), V'O2 peak (+3.1 mL/kg per minute, P = 0.0099), muscular strength in plantar flexor (+12 kg, P = 0.0368), height in the countermovement jump (+1.9 cm, P = 0.0293) and decreased in Body Mass Index (-0.5 kg/m2, P = 0.0013). HRQoL significantly improved in physical function (P = 0.0019), physical-role limitations (P = 0.0321) and social functioning scales (P = 0.0346). No improvements were found in Group B. CONCLUSION: Twelve-month of supervised aerobic and resistance training improves the physiological variables related to physical fitness and cardiovascular risks without consequences on renal function. Recommendations alone are not sufficient to induce changes in exercise capacity of KTRs. Our study is an example of collaborative working between transplant centres, sports medicine and exercise facilities.

Infections in liver and lung transplant recipients: a national prospective cohort.

Infections are a major complication of solid organ transplants (SOTs). This study aimed to describe recipients' characteristics, and the frequency and etiology of infections and transplant outcome in liver and lung SOTs, and to investigate exposures associated to infection and death in liver transplant recipients. The study population included recipients of SOTs performed in Italy during a 1-year period in ten Italian lung transplant units and eight liver transplant units. Data on comorbidities, infections, retransplantation, and death were prospectively collected using a web-based system, with a 6-month follow-up. The cumulative incidence of infection was 31.7% and 47.8% in liver and lung transplants, respectively, with most infections occurring within the first month after transplantation. Gram-negatives, which were primarily multidrug-resistant, were the most frequent cause of infection. Death rates were 0.42 per 1000 recipient-days in liver transplants and 1.41 per 1000 recipient-days in lung transplants. Infection after SOT in adult liver recipients is associated to an increased risk of death (OR = 13.25; p-value < 0.001). Given the frequency of infection caused by multidrug-resistant microorganisms in SOT recipients in Italy and the heavy impact of infections on the transplant outcome, the reinforcement of surveillance and control activities to prevent the transmission of multidrug-resistant microorganisms in SOT recipients represents a priority. The implementation of the study protocol in liver and lung transplant units and the sharing of results have increased the awareness about the threat due to antimicrobial resistance in the country.

Organ transplantation from "increased infectious risk donors": the experience of the Nord Italia Transplant program - A retrospective study.

The purpose of this study was to assess the safety and the clinical outcome associated with organ transplantation from increased infectious risk donors (IRD). We retrospectively identified all adult deceased IRD referred to the Nord Italia Transplant program coordinating center from November 2006 to November 2011. All potential donors were screened for social risk factors that may increase the risk of donor-derived infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). All recipients were followed monthly for the first 6 months post-transplant. A total of 86 potential IRD were identified during the study period. Three hundred and seventy-nine organs from IRD were offered to the transplant centers, but only 185 (48.8%) were used for transplantation. Organs from IRD were transplanted into 174 recipients. The complete follow-up data were available for 152 of 174 (87.3%) recipients. During a mean follow-up of 11.7 months (median 12; range 2.4-12), no transmission of HIV, HBV, or syphilis was documented by serology and nucleic acid testing (NAT) testing. Two patients transplanted with organs from HCV-RNA-positive donors, as expected, developed post-transplant HCV infection. In conclusion, the use of organs from IRD was associated with a safe increase in the transplant procedures in our country.

The effect of differing kidney disease treatment modalities and organ donation and transplantation practices on health expenditure and patient outcomes.

The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and Transplantation Practices on Health Expenditure and Patient Outcomes (EDITH) aims to obtain information on long-term kidney transplant outcomes, long-term health outcomes of living kidney donors and detailed outcomes and costs related to the different treatment modalities of end-stage kidney disease. Nine partners from seven European Union countries will participate in this project.

From the EU Legislation to the Application of the Single European Code: Support to the Implementation.

The Italian National Transplant Centre (CNT) is coordinating with the Italian National Blood Centre (CNS) the Joint Action '!' (www.eurocet128.eu), already built the European Tissue Establishment and Tissue and Cell Product Compendia between 2011 and 2014 in order to provide European Member States with a tool which would grant traceability of tissues and cells at human transplant purpose across the European Union. The two compendia are available on an online platform hosted and managed by the European Commission.

Renal transplantation in sensitized children and young adults: a nationwide approach.

Background: High levels of preformed anti-HLA antibodies dramatically diminish renal transplant outcomes. Most desensitization programmes guarantee good intermediate outcomes but quite disappointing long-term prognosis. The search for a fully compatible kidney increases time on the waiting list. Methods: In February 2011, a nationwide hyperimmune programme (NHP) was begun in Italy: all available kidneys are primarily proposed to highly sensitized patients with a panel reactive antibody above 80%. In this manuscript, we evaluate the outcome of paediatric patients transplanted with this approach. Results: Twenty-one patients were transplanted. Complete data are available for 20 patients. Mean age at transplantation was 14.5 years [standard deviation (SD) ± 5.5)]. Mean time on the waiting list was 29.3 months (SD ± 27.5). Median follow-up was 29.2 months (range: 11.2-59.3). The average number of HLA mismatches in these patients was 2.3 versus 3.7 in 48 standard patients transplanted in the same period (P < 0.001). Only one graft was lost. Two cases of humoral rejection occurred and were successfully treated. No cellular rejection was reported. Median creatinine clearance was 84, 88, 77 and 77 mL/min/1.73 m 2 respectively 1, 6, 12 and 24 months after transplant. Conclusions: Transplantation of sensitized patients avoiding prohibited antigens is feasible, at least in a selected cohort of patients. In order to be able to further improve this approach, which in our opinion is very successful, it would be necessary to expand the donor pool, possibly increasing the number of countries participating in the programme. In this series, time on the waiting list did not increase significantly. This allocation policy should ideally lead to an outcome comparable to that expected in standard patients, which is particularly desirable in young patients who have the longest life expectancy. Since long-term results of desensitization programmes are not (yet) convincing, we suggest that these programmes should be reserved for selected cases where compatible organs cannot be found within a reasonable time span.

Organ transplantation and gender differences: a paradigmatic example of intertwining between biological and sociocultural determinants.

Organ transplantation, e.g., of the heart, liver, or kidney, is nowadays a routine strategy to counteract several lethal human pathologies. From literature data and from data obtained in Italy, a striking scenario appears well evident: women are more often donors than recipients. On the other hand, recipients of organs are mainly males, probably reflecting a gender bias in the incidence of transplant-related pathologies. The impact of sex mismatch on transplant outcome remains debated, even though donor-recipient sex mismatch, due to biological matters, appears undesirable in female recipients. In our opinion, the analysis of how sex and gender can interact and affect grafting success could represent a mandatory task for the management of organ transplantation.

Impact of cord blood banking technologies on clinical outcome: a Eurocord/Cord Blood Committee (CTIWP), European Society for Blood and Marrow Transplantation and NetCord retrospective analysis.

BACKGROUND: Techniques for banking cord blood units (CBUs) as source for hematopoietic stem cell transplantation have been developed over the past 20 years, aimed to improve laboratory efficiency without altering the biologic properties of the graft. A large-scale, registry-based assessment of the impact of the banking variables on the clinical outcome is currently missing. STUDY DESIGN AND METHODS: A total of 677 single cord blood transplants (CBTs) carried out for acute leukemia in complete remission in centers affiliated with the European Society for Blood and Marrow Transplantation were selected. An extensive set of data concerning CBU banking were collected and correlations with clinical outcome were assessed. Clinical endpoints were transplant-related mortality, engraftment, and graft-versus-host disease (GVHD). RESULTS: The median time between collection and CBT was 4.1 years (range, 0.2-16.3 years). Volume reduction (VR) of CBUs before freezing was performed in 59.2% of available reports; in half of these the frozen volume was less than 30 mL. Cumulative incidences of neutrophil engraftment on Day 60, 100-day acute GVHD (II-IV), and 4-year chronic GVHD were 87, 29, and 21 ± 2%. The cumulative incidence of nonrelapse mortality (NRM) at 100 days and 4-year NRM were, respectively, 16 ± 2 and 30 ± 2%. Neither the variables related to banking procedures nor the interval between collection and CBT influenced the clinical outcome. CONCLUSION: These findings indicate a satisfactory validation of the techniques associated with CBU VR across the banks. Cell viability assessment varied among the banks, suggesting that efforts to improve the standardization of CBU quality controls are needed.