Abstract: Ischemia reperfusion injury (IRI) is the primary cause of early complications in kidney transplantation and contributes to impaired graft function. Mitochondrial DNA (mtDNA), which is implicated in IRI-induced organ damage, has shown promise as a biomarker for assessing and predicting organ function, though studies have focused primarily on deceased donor transplantation. This post-hoc analysis of the VAPOR-1 study aimed to explore the presence, dynamics, and prognostic value of urinary mtDNA in a cohort of 57 living donor kidney transplantation (LDKT) recipients. Surprisingly, higher mtDNA gene levels in the first urine after transplantation were associated with higher estimated glomerular filtration rate (eGFR) at 12 as well as with an increase in eGFR between month 1 and month 24 after transplantation. These findings suggest that, contrary to prior assumptions of mtDNA as a damage marker, early urinary mtDNA levels may reflect graft function rather than injury. This study underscores the potential of urinary mtDNA as a prognostic tool for renal allograft function and advocates for a re-evaluation of the way early posttransplantation renal damage markers are interpreted in LDKT.

Abstract: Ojectives: This article explores the use of ECMO therapy in patients with end-stage respiratory failure who need lung transplantation (LTx). ECMO has several roles: it can bridge patients to transplantation, condition the lung graft in case of primary graft dysfunction after transplantation, condition the the left ventricle after transplantation in patients with primary pulmonary hypertension, and manage COVID-19 patients who are awating LTx or undergoing LTx. Methods: We present 6-year results from high volume lung transplant center (219 cases/6years, >50 cases/2022). We used ECMO in 56 cases (25.6%) of all lung transplants be- tween 2018 and 2023. Results: The one-year survival rate of patients transplanted on ECMO was 85.7% (95%CI: 77.0-95.4%). We applied all advanced ECMO techniques, such as bridging to transplantation on ECMO (n=15, early survival 66.7%), left ventricular conditioning after LTX with VA-ECMO protocol (n=12, 60-day and one-year survival 85.1% and 53% respectively) and the most advanced variant of ECMO such as Sport-ECMO (n=7). We also bridged to transplantation patients with COVID-19 and were among the first in Europe to transplant them from ECMO (n=9, early survival 55%). Conclusions: This article shows possible applications of ECMO therapy for various indications in lung transplant patients and along with data from other publications it demonstrates that ECMO can improve survival and outcomes in patients with end-stage respiratory failure, primary pulmonary hypertension, and COVID-19. The COVID-19 pan- demic highlighted new utilization of ECMO,demonstrating its usefulness and importance in critical care medicine. Further research into the capabilities of the ECMO system may expand knowledge about its role in lung transplantation and future treatments.

Abstract: Background/Objectives: Liver transplantation (LT) is often complicated by severe bleeding and coagulopathy. Viscoelastic testing (VET) offers real-time, bedside assessment of coagulation and may improve transfusion management compared to standard tests. This study evaluates the clinical impact of VET implementation during liver transplantation on bleeding, transfusion requirements, complications, and mortality. Methods: We conducted a single-center before-and-after study comparing patients undergoing LT before and after the implementation of VET. All procedures were performed by the same surgical and anesthetic team using a standardized protocol. Data were collected retrospectively for the Before VET group and prospectively for the After VET group. We compared transfusion requirements, bleeding, complications, and mortality. Results: A total of 59 patients were included, 22 in the After VET group and 37 in the Before VET group. VET implementation was associated with lower intraoperative blood loss (median 4000 mL vs. 6000 mL, p = 0.017) and reduced allogeneic blood transfusion (670 mL vs. 1000 mL, p = 0.008). FFP (0.23 vs. 1.59 units, p = 0.007) and platelet use (0.68 vs. 1.81 units, p = 0.035) were also significantly lower in the VET group, while fibrinogen use was higher (3.00 g vs. 2.00 g, p = 0.036). No differences were observed in complication rates or mortality at 30 days and 1 year. Conclusions: VET significantly improved transfusion precision and individualized coagulation management during LT, leading to reduced use of blood products. These findings support the adoption of VET as a standard of care in LT protocols, as it may enhance patient safety, even though no differences in postoperative complications or mortality were observed.

Abstract: Kidney transplantation significantly improves outcomes in patients with end-stage renal disease; however, postoperative complications remain a substantial concern. This review summarizes the incidence, risk factors, and management strategies for common complications after kidney transplantation. Reported incidence varies widely due to differences in definitions, diagnostic methods, and study designs. Ureteral stenosis occurs in 2.8–18.0% of recipients, vesicoureteral reflux in 0.5–86%, and urinary leakage in 1.1–7.2%. Lymphatic complications, including lymphocele and lymphorrhea, range from 0.6% to 35.2%, with one-third requiring intervention. The incidence of urinary tract infections ranges from 20–43%, while asymptomatic bacteriuria is reported in up to 53% of recipients. Surgical site infections have a median incidence of 3.7%, and incisional hernias develop in 2.5–10% of cases, depending on follow-up duration. Vascular complications affect approximately 10% of recipients, with renal artery stenosis and thrombosis being the most prevalent. Neurologic complications, such as femoral nerve palsy and immunosuppression-related neurotoxicity, though less frequent, can impair recovery. Management strategies vary depending on severity, ranging from observation to surgical intervention. Preventive measures—including optimized ureteral stenting protocols, early catheter removal, careful immunosuppression, and appropriate antimicrobial use—play a crucial role in reducing complication risk. Despite advances in transplantation techniques and perioperative care, these complications continue to affect graft survival and patient outcomes. Further research is needed to standardize definitions and establish evidence-based protocols.

Abstract:

In the application of the digital twin model of the digging face, the data transmission will be transmitted to the remote control platform through the physical hardware via the gateway, and this cross-system and cross-software data transmission mode will inevitably generate the transmission delay, which leads to a certain spatial-temporal deviation between the virtual scene of the remote control platform and the physical digging site. In this paper, by analyzing the operation process of roadheading equipment, a state evolution dynamics model construction method for roadheading equipment is proposed, which includes three stages, namely, discretization of positional state based on cutting path planning, event-driven construction of cutting state evolution map of roadheading equipment and real-time data-driven dynamics evolution of roadheading equipment, and the construction of roadheading equipment state evolution dynamics model provides the best solution for the roadheading equipment. The construction of the model provides theoretical basis and technical support for the construction and alignment of the digital twin multidimensional model of the roadheading equipment.

Abstract: Background / Objectives: While there are several debates on en bloc renal transplants and pediatric donors regarding its efficacy and concern for renal mass, multiple studies have supported the notion that transplanting pediatric en bloc kidneys produces comparable results in contrast to single kidneys from living or deceased donors. Methods: This case series was a retrospective analysis of a university medical center, primarily focused on comparing the post-operative outcomes between recipients of pediatric and adult en bloc kidneys, which are horseshoe kidneys, from deceased donors and recipients of single adult kidneys from living or deceased donors. Results: The study demonstrated that the post-operative results in recipients of pediatric en bloc kidneys consisting of serum creatinine and eGFR values were lower and higher, respectively, and had a comparable improvement in kidney function at post-transplant, 1-week, 1-month, 3-months, and 1-year post-op marks. Conclusion: The data and results at this university medical center support the notion that en bloc kidney transplantations from pediatric donors result in superior outcomes compared to that of single kidney transplantations from living or deceased donors.

Abstract: Liver transplant recipients (LTR) have been considered a population group vulnerable to COVID-19 disease as they are chronically immunosuppressed patients with frequent comorbidities. This study describes the course of SARS-CoV-2 disease from February 2020 to December 2023 along seven pandemic “waves". We carried out an observational study on a 307 COVID-19 cases cohort in LTR with the aim of evaluating the changes in the disease characteristics over time and determining the risk factors for severe COVID-19. Older age and serum creatinine ≥ 2 mg/dL were found to be risk factors for hospital admission and respiratory failure. Calcineurin inhibitors was a protective factor for death from COVID-19, hospitalization and respiratory failure. 100% of patients who died (N = 12) were on mycophenolate mofetil, which was a determinant for respiratory failure. Azathioprine was associated with admission to the Intensive Care Unit (ICU) and with invasive mechanical ventilation (IMV). Vaccination was a protective factor for hospitalization, respiratory failure and mortality. Severe COVID-19 rate was higher during the first five waves, with a peak of 57.14% and the highest mortality rate (21.43%), in the 4th wave. IMV and ICU admission rates did not show significant differences across the periods.

Abstract: The Human Leukocyte Antigens (HLA) system forms the central part of the immune system and is crucial in the recognition and elimination of „non-self“ antigens. While this role of the HLA system is essential in the effective defense of the organism against pathogens, it is undesirable in organ and tissue transplantation because it enables the recognition of mismatched HLA molecules of the donor as foreign and stimulates the graft rejection reaction. Organ transplantation involves the introduction of antigens that are more or less mismatched to the recipient, so in order to achieve the best possible match in the HLA system between the recipient and the donor, a whole series of immunogenetic tests is performed, including cross-matching (XM). If performed before kidney transplantation, it represent the final in vitro test to rule out the presence of donor-specific antibodies, which may cause graft rejection, and which may not have been detected by earlier serum screening. The beginning of XM was marked by the complement-dependent cytotoxicity (CDC) method developed by Terasaki and colleagues in 1964. Later, as a result of advances in technology and the need for methods that overcome the limitations of CDC, flow cytometry and Luminex XM assays were developed. The introduction of solid-phase technology in the early 2000s brought a new dimension to the detection of low-level HLA antibodies and the determination of their specificities, which enabled the development and implementation of the virtual XM test (vXM). It is an in silico test that assesses the immunological match between the recipient and the organ donor based on the analysis of the specificity of the antibodies present in the recipient's serum and the HLA typing of the organ donor. Each method has its own advantages and limitations which are described and which need to be taken into account considering their significant impact on clinical application in kidney transplantation.

Abstract: Liver transplantation is well described as the only curative treatment for cirrhosis and cirrhosis with co-morbid hepatocellular carcinoma (HCC). However, it’s utility in the management of various other primary and secondary liver cancers is gaining traction rapidly, with more thorough and broader populations continuing to qualify. This includes most prominently colorectal cancer liver metastasis (CRLM), as well as cholangiocarcinoma (CCA), neuroendocrine tumors (NET) and more. Furthermore, despite being a well-described treatment for HCC for many years, growing evidence supports a change in oncologic strategy for HCC, with broadened selection criteria and more advanced systemic and loco-regional therapies. Our review aims to describe the evidence supporting expanding indications and selection criteria for liver transplantation for various oncologic indications of primary and secondary liver tumors.

Abstract: Kidney transplant recipients (KTRs) are at high risk of severe COVID-19 outcomes due to chronic immunosuppression, which can impair vaccine efficacy. While mycophenolate sodium (MPS) and azathioprine (AZA) are commonly used immunosuppressive agents, their influence on anti-SARS-CoV-2 antibody kinetics remains unclear. This study compares the humoral response in KTRs receiving MPS or AZA after ChAdOx1 primary vaccination. Methods: This prospective, observational, single-center study included 89 KTRs who had undergone transplantation and seroconverted following ChAdOx1 vaccination. Patients were grouped based on maintenance immunosuppression: MPS (n=51) or AZA (n=38). Anti-SARS-CoV-2 IgG titers and neutralizing antibody activity were measured at screening and 1-, 3-, 6-, and 12-months post-transplant. Linear regression models and generalized estimating equations were applied to analyze group and time effects. Results: At baseline, IgG titers were 12,059.2 AU/mL (MPS) and 14,369.3 AU/mL (AZA), with both groups experiencing a decline at month 1 (9,483.9 AU/mL and 11,023.5 AU/mL, respectively). By month 12, titers stabilized at 11,626.8 AU/mL (MPS) and 13,851.4 AU/mL (AZA; p=0.286). Neutralizing antibody activity was initially higher in the AZA group (0.924 vs. 0.764 at baseline; p=0.006) but converged with the MPS group by month 3 (0.937 vs. 0.871; p=0.161). Booster doses significantly enhanced responses, with a mean gain of 0.175 in neutralizing activity over 12 months. Conclusions: AZA offers a transient early advantage in humoral responses compared to MPS, but long-term antibody kinetics were comparable. Booster doses are critical for sustaining immunity in KTRs, underscoring the need for tailored vaccination strategies in this population. These findings may guide clinical decisions during pandemic scenarios.

Abstract: Static ice storage (SIS) is the historic standard for lung preservation. It has been assumed that SIS results in 4°C organ temperatures. However, no prior studies measured lung temperature during SIS, potentially reaching near-freezing conditions. We aimed to measure lung and preservation temperature dynamics with SIS in porcine experiments and clinical observations. Methods: Porcine lungs were preserved with SIS for 8h (group I, n=3) and 3h followed by 10°C storage (group II, n=3). Tissue (tissueT°), 1st bag preservation solution (psT°) and 2nd bag saline (salineT°) temperature were monitored. In clinical lungs (n=4), psT° was monitored during SIS. Surface (surfaceT°) and core (coreT°) temperature were assessed before and after SIS (n=62). Results: After 4h in group I, average tissueT° was 0.66°C, psT° was 0.12°C, salineT° was -0.02°C. After 3h in group II, average tissueT° was 1.90°C, psT° was 0.57°C, salineT° was 2.33°C. In clinical observations, psT° was below 4°C after 9-13min and 0°C after 78-267min. After SIS, median surfaceT° was 1.25°C (min-max; -3.2°C – 9.2°C) , and coreT° was 1.45°C (-0.4°C – 4.8°C). Conclusions: SIS leads to rapid temperature drops below 4°C, approaching 0°C within 2-4 hours. Post-SIS lung temperature shows considerable variability and does not consistently remain at the commonly assumed 4°C, posing potential freezing injury to donor lungs.

Abstract: Kidney transplantation stands as the preferred treatment for end-stage kidney disease, significantly improving both the quality and longevity of life compared to dialysis. In recent years, the survival rates for patients and grafts have markedly increased thanks to innovative strategies in desensitization protocols for incompatible transplants and advancements in immunosuppressive therapies. Although the initial expenses associated with transplantation may exceed those of dialysis, it proves to be more cost-effective in the long run. Despite its numerous benefits, the widespread adoption of kidney transplantation faces several challenges, notably a scarcity of donated organs, financial limitations, and unequal access among various populations. Additionally, there is a shortage of healthcare professionals equipped with the requisite expertise. For kidney transplant recipients, preventing allograft rejection is of paramount importance, necessitating the use of immunosuppressive medications. Regular follow-up appointments are essential, as monitoring the function of the kidney allograft is critical. Currently, established biomarkers such as serum creatinine, estimated Glomerular Filtration Rate (eGFR), proteinuria, and albuminuria are commonly employed to assess allograft function. However, these biomarkers have limitations, as elevated levels often indicate significant allograft damage only after it has occurred, thereby constraining treatment options and the potential for restoring graft function. Additionally, kidney biopsies, while considered the gold standard for diagnosing rejection, are invasive and carry associated risks. Consequently, the identification and development of new, sensitive, and specific biomarkers for allograft rejection are crucial. To tackle this challenge, intensive ongoing research employing cutting-edge technologies, including “omics” approaches, is uncovering a variety of promising new biomarkers.

Abstract: Asystole Donation (AD) or donation after cardiac death (DCD) has been shown to be a potential source of transplantable organs. To date, no reports of face procurement with AD has been described, and the “face in first place” with ex-situ perfusion has became the gold standard technique of recovering facial allografts in most of the centers. We report a case of successful total graft face and kidneys procurement from a 47 years old male AD donor. Immediately, after confirmation of death, the “rapid recovery” technique was performed and cannula placed in ascending aorta for face allograft in situ perfusion simultaneously to the abdominal team. Total ischemia time from donor cardiac death to face reperfusion in the recipient was 5.5 hours. Excellent function for kidneys and face allograft was reported.

Abstract:

Lung cancer is a leading cause of cancer-related mortality worldwide, largely due to its heterogeneity and intrinsic drug resistance. Malignant pleural effusions (MPE) provide diverse tumor cell populations ideal for studying these complexities. Although chemotherapy and tar-geted therapies can be initially effective, subpopulations of cancer cells with phenotypic plasticity often survive treatment, eventually developing resistance. Here, we integrated single-cell isola-tion and three-dimensional (3D) spheroid culture to dissect subclonal heterogeneity and drug responses, aiming to inform precision medicine approaches. Using A549 lung cancer cells, we established a cisplatin-resistant line and isolated three resistant subclones (Holoclone, Meroclone, Paraclone) via single-cell sorting. In 3D spheroids, Docetaxel and Alimta displayed higher IC50 values than in 2D cultures, suggesting that 3D models better reflect clinical dosing. Additionally, MPE-derived Holoclone and Paraclone subclones exhibited distinct sensitivities to Giotrif and Capmatinib, revealing their heterogeneous drug responses. Molecular analyses confirmed ele-vated MDR-1, ABCG2, cancer stem cells (CSC) markers (OCT4, SOX2, CD44, CD133), and epi-thelial-mesenchymal transition (EMT) markers (E-cadherin downregulation, increased Vimentin, N-cadherin, Twist) in resistant subclones, correlating with enhanced migration and invasion. This integrated approach clarifies the interplay between heterogeneity, CSC/EMT phenotypes, and drug resistance, providing a valuable tool for predicting therapeutic responses and guiding per-sonalized, combination-based lung cancer treatments.

Abstract: Liver transplantation is a critical and evolving field in modern medicine, offering life-saving treatment for patients with end-stage liver disease and other hepatic conditions. Despite its transformative potential, transplantation faces persistent challenges, including a global organ shortage, increasing liver disease prevalence, and significant waitlist mortality rates. Current donor evaluation practices often discard potentially viable livers, underscoring the need for refined graft assessment tools. This review explores advancements in graft evaluation and utilization aimed at expanding the donor pool and optimizing outcomes. Emerging technologies, such as imaging techniques, dynamic functional tests, and biomarkers, are increasingly critical for donor assessment, especially for marginal grafts. Machine learning and artificial intelligence, exemplified by tools like LiverColor, promise to revolutionize donor-recipient matching and liver viability predictions, while bioengineered liver grafts offer a future solution to the organ shortage. Advances in perfusion techniques are improving graft preservation and function, particularly for donation after circulatory death (DCD) grafts. While challenges remain—such as graft rejection, ischemia-reperfusion injury, and recurrence of liver disease—technological and procedural advancements are driving significant improvements in graft allocation, preservation, and post-transplant outcomes. This review highlights the transformative potential of integrating modern technologies and multidisciplinary approaches to expand the donor pool and improve equity and survival rates in liver transplantation.

Abstract: Liver ischaemia-reperfusion (IR) injury remains a major cause of morbidity and mortality following liver transplantation and resection. CD4+ T cells have been shown to play a key role in murine models however there is currently a lack of data to support their role in human patients. Methods: Data on clinical outcomes and complications were documented prospectively in 28 patients undergoing first elective liver transplant surgery. Peripheral blood samples were collected at baseline (pre-op), 2 hours post graft reperfusion, immediately post-op and at 24 hours post-op. A post reperfusion biopsy was analysed in all patients and in 5 patients a donor liver biopsy was available pre-implantation. Circulating cytokines were measured and T cells were analysed for activation markers and cytokine production. Results: Circulating levels of cytokines associated with innate immune cell recruitment and activation were significantly elevated in the peri-transplant period. High circulating IL-10 levels corresponded with the development of graft-specific complications. The proportion of CD4+ T cells in the peripheral circulation fell throughout the peri-operative period suggesting CD4+ T cell recruitment to the graft. Although TNF was the predominant cytokine produced by CD4+ T cells in the intra-hepatic environment, production of IFN was significantly upregulated by circulating CD4+ T cells. Furthermore we demonstrated clear recruitment of inflammatory monocytes in the peri-operative period. In donor and recipient pairs with a mismatch at the HLA-A2 or A3 allele we demonstrated that inflammatory monocytes in the liver are recipient-derived. Discussion: This is the first study to our knowledge to track early immune cell responses in humans undergoing liver transplantation. The recruitment of inflammatory monocytes from the recipient and their cytokine release is associated liver specific complications. Inflammatory monocytes would be an attractive target to ameliorate ischaemia reperfusion injury.

Abstract: Osteoarthritis (OA) is the most common rheumatologic disease and a major cause of pain and disability in older adults. No efficient treatment is currently available. Mitochondrial dysfunc-tion in chondrocytes promotes the molecular dysregulation involved in OA pathogenesis, making transplant of mitochondria as a potential therapeutic targets for treating OA. Mitochondria were isolated from liver using a combining the procedure described by Preble and coworkers with magnetic beads coupled to anti-TOM22 antibodies. The organelles obtained were analyzed to determine their purity and viability. The safety and viability of administration isolated mitochondria into articular tissues as well as the integration and distribution of transplanted mitochondria within joint tissues were analyzed using both in vitro and in vivo models. We estab-lished an efficient, reproducible, effective, and rapid protocol for isolating mitochondria from liver. We obtained mitochondria with high viability, yield, and purity. The isolated mitochondria were injected into joint tissue using both in vitro and in vivo models. Functional mitochondria were detected in the extracellular matrix of the cartilage, menisci and synovium. Our results indicate that mitochondrial transplantation is safe for treating joint alterations. The procedure and data described here support further studies on mitochondrial transplantation as an efficient treatment for OA.

Abstract: The rising use of liver grafts from donation after circulatory death (DCD) has been enabled by advances in normothermic regional perfusion (NRP) and machine perfusion (MP) technologies. Our study aimed to identify predictive biomarkers in DCD liver grafts subjected to NRP, followed by randomization to either normothermic machine perfusion (NMP) or dual hypothermic oxygenated perfusion (D-HOPE). Among 57 DCD donors, 32 liver grafts were transplanted, and recipients were monitored for one week after transplantation. Biomarkers linked with oxidative stress, hepatic injury, mitochondrial dysfunction, inflammation, regeneration, and autophagy gene expression were measured during NRP, end-ischemic MP, and one week post-transplant. Arginase-1(ARG-1) levels were consistently higher in discarded grafts and recipients who later developed early allograft dysfunction (EAD). Specifically, ARG-1 levels at the end of ex-situ machine perfusion correlated significantly with other markers of hepatic injury. Receiver Operating Characteristic analysis indicated that ARG-1 at the end of MP had good predictive accuracy for EAD (AUC = 0.713 [95% CI: 0.538-1]; p = 0.02). Additionally, lipid peroxidation, measured by TBARS, was elevated at the start of NRP but declined over time, with higher levels in D-HOPE than in NMP, suggesting a more sustained oxidative environment. Metabolites like Flavin mononucleotide (FMN) and NADH exhibited significant disparities between perfusion types, due to differences in perfusate compositions. Inflammatory biomarkers rose during NRP and NMP but normalized post-transplantation. Regenerative markers, including osteopontin and hepatocyte growth factor, also increased during NRP and NMP and normalized after transplantation. In conclusion, ARG-1 demonstrates strong potential as an early biomarker for assessing liver graft viability during perfusion, supporting timely and effective decision-making in transplantation.

Abstract: Background/Objectives: The University of Wisconsin (UW) solution is the gold standard for kidney preservation. The addition of quercetin (QE) to the preservation solution reduces damage to renal kidney tubular cells, and the addition of sucrose (Suc) is beneficial for kidney preservation. The aim of this study was to investigate the protective effects of QE and Suc and to evaluate whether their use improves mitigates ischemia-reperfusion (I/R) injury after simple cold storage (CS) in porcine kidneys. Methods: Kidney grafts were procured after 30 min of warm ischemia, followed by preservation under two conditions for 22 h: group 1, preserved with CS/UW solution (n = 4), and group 2, preserved with CS/UW solution containing QE (33.1 μM) and Suc (0.1 M; (n = 6). All grafts were evaluated using an ex- vivo isolated kidney- reperfusion model with oxygenated, diluted, autologous blood at room temperature. Results: At the end of reperfusion, creatinine phosphokinase and lactate dehydrogenase levels were significantly lower in group 2 than those in group 1. Additionally, group 2 had a significantly higher number more of anti-ERG-positive endothelial- cell nuclei than group 1 at the end of reperfusion. Conclusions: Our results suggest that the addition of QE and Suc to the UW solution can improve mitigate I/R injury to the donated kidney after CS.

Abstract: The therapeutic applicability of mesenchymal stem cells (MSC) for a range of conditions has garnered increasing interest. This study aimed to evaluate the mean major adverse cardiac and cerebrovascular event (MACCE)-free period in a population of 2,504 patients (age, 54.09 ± 11.65 years) receiving MSC therapy (mean dose, 1.49 ± 0.75 billion cells) for various indications (over two-thirds [n=1,700, 67.89%] received MSC therapy as an anti-ageing therapy) and evaluate for potential risk factors for MACCE development in this cohort. In multivariate Cox proportional hazards regression analysis, age, but not sex and MSC dose, was significantly associated with MACCE risk (hazard ratio=1.127; 95% confidence interval=1.0418, 1.219; p=0.0029). The adverse event rate was 0.8%, and none of the reported adverse events were severe. In conclusion, our study showed that stem cell therapy was safe in a large cohort of individuals and was associated with a low rate of MACCE.