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See detailThird-party mesenchymal stem cell infusion in kidney transplant recipient: 6-month safety interim analysis
WEEKERS, Laurent ULg; ERPICUM, Pauline ULg; DETRY, Olivier ULg et al

in Transplant International (2015, November), 28(S4), 223-224278

Background: Mesenchymal stromal cell (MSC) have immunomodulating properties and could be used as immunosuppressive agents. We report the 6- month safety results for the 5 first patients treated with MSC ... [more ▼]

Background: Mesenchymal stromal cell (MSC) have immunomodulating properties and could be used as immunosuppressive agents. We report the 6- month safety results for the 5 first patients treated with MSC after kidney transplantation (KTx). Here, we address 3 specific safety issues: immunization against MSC and engraftment syndrome defined as acute graft dysfunction not related to rejection and over-immunosuppression. Patients and method: MSC production was carried out locally. MSC were not matched with kidney recipients’ HLA. Included patients were non-immunized, first transplant recipients from deceased donors. MSC (1.5–3.0 9 106/kg) infusion was planned 3 to 5 days post KTx. Patients with cardiovascular instability post KTx were excluded. All patients were treated with Basiliximab induction, Tacrolimus, Mycophenolate Mofetil and Steroid. We prospectively screened for anti-HLA antibodies at month 1, 3 and 6. Informed consent was obtained from all participants. The local ethical committee approved the protocol. Results: Collectively there were 23/50 and 29/50 HLA mismatches (MM) with kidney and MSC donor respectively, out of which 5 were shared MM. One patient developed de novo DSA, 2 patients anti-HLA antibodies against shared kidney/MSC MM and 1 patient developed 2 specific antibodies against MSC (MSCSA) at month 6. All antibodies were anti HLA class I except for 1. We did not observe any “engraftment” syndrome. Three patients experienced non- severe opportunistic infections: 1 CMV reactivation and 2 polyoma-BK virus viremia.Conclusion: We did not observe any strong safety signal. We did however observe some degree of immunization in 3 patients: 2 developed antibodies against shared kidney/MSC donor HLA MM and 1 MSCSA. [less ▲]

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See detailComparable transplant outcomes between DBD and DCD kidney grafts up to 5 years post-transplant: single centre experience
Ledinh, H; DETRY, Olivier ULg; DE ROOVER, Arnaud ULg et al

in Transplant International (2015, November), 28(S4), 193-194188

Introduction: This study aimed to determine the most recent results of kidney transplantation (KT) from donation after brain death (DBD) and circulatory death (DCD). Primary endpoints were graft and ... [more ▼]

Introduction: This study aimed to determine the most recent results of kidney transplantation (KT) from donation after brain death (DBD) and circulatory death (DCD). Primary endpoints were graft and patient survival, and graft function. Acute rejection and post-operative complications were assessed as secondary endpoints. Patient and Methods: This retrospective mono-center review consisted of 226 DBD- and 104 DCD-KT between 2008 and 2014. Results: Graft survival was comparable between two groups (95.1 vs. 91.1% at 1 year, 92.8 vs. 91.1% at 3 years and 89.2 vs. 91.1% at 5 years). 46% and 40% of graft loss were attributed to patient death with a functioning graft and rejection. Patient survival was comparable between 2 groups (97.8 vs. 95.1% at 1 year, 94.1 vs. 91.2% at 3 years, and 89.6 vs. 82.3% at five years). Etiology of patient death included cardiac arrest (16.7%), infection (16.7%), cancer (13.3%), and unknown cause (46.7%). Delayed graft function occurred in 14.6% of DBD- and 30.8% of DCD-KT (p = 0.001). Primary non function was encountered in 2.6% DBD- and 4.8% DCD-KT (p = ns). Graft function was worse in DCD than DBD up to 3 months post-transplant (p = 0.034), however, no difference existed afterwards. Biopsy-proven acute rejection was found in 12.8% and 13.5% of DBD- and DCD-KT during an average 3 months post- transplant (p = ns). This rate was 7.1% vs. 8.9% on surveillance biopsy performed between 3 and 6 months post-transplant (p = ns). Post-operativecomplication rate was comparable between 2 groups, concerning patient death, reoperation, transfusion, perirenal hematoma, macroscopic hematuria, urinary obstruction, wound problem, and infection. Nevertheless, contamination of preservation solution occurred more commonly in DCD than DBD (0.4% vs. 3.8%, p = 0.036). Conclusions: Despite worse early graft function, DCD-KT was not inferior to that originating from DBD up to 5 years post-transplant, therefore deserves to be used. [less ▲]

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See detailInfusion of third-party mesenchymal stream cells after liver transplantation: a phase-1, open-label, clinical study
DETRY, Olivier ULg; VANDERMEULEN, Morgan ULg; DELBOUILLE, Marie-Hélène ULg et al

in Transplant International (2015, November), 28(S4), 1027

Background: Mesenchymal stromal cells (MSC) are multipotent bone mar- row progenitors that have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aimed ... [more ▼]

Background: Mesenchymal stromal cells (MSC) are multipotent bone mar- row progenitors that have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aimed to be the first evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled phase-1 study. Methods: 10 liver transplant recipients under standard immunosuppression (TAC-MMF-low dose steroids until day 30) received 1.5–3 9 106/kg third party MSC on post-operative day 3 ` 2. These patients were prospectively compared to a group of 10 control liver recipients. Primary endpoints were MSC infusion toxicity, and incidence of cancer and opportunistic infections at month 6. Secondary endpoints were patient and graft survivals and rejection at month 6, as well as the effects of MSC on recipients’ immune function and on immunohistology of at month 6 graft biopsies. Results: No MSC infusional toxicity was observed. Both groups were comparable in terms of donor and recipient characteristics. There was no difference in primary end-points between control and MSC groups. No patient developed de novo cancer. There was no statistical difference in patient and graft survivals or in rejection rates. There was no graft rejection in the MSC group. Month-6 graft biopsies were not different according to Banff and fibrosis scores. Discussion: This phase 1 study showed excellent tolerability and safety of a single infusion of third-party MSC after liver transplantation. There were no graft safety issues and no excess of immunosuppression after MSC injection. Further analyses of consequences of MSC injection on the immune profile are needed. The possibility of avoiding calcineurin-inhibitors with repeated MSC injections as main immunosuppressive therapy and/of tolerance induction by MSC infusion should be investigated by further studies. This study is in part supported by an ESOT Senior Clinical Research Grant and by the University of Liege. [less ▲]

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See detailImpact of timing administration of mesenchymal stromal cells on serum creatinine following renal ischemia/ reperfusion in rats
ERPICUM, Pauline ULg; Rowart, Pascal ULg; POMA, Laurence ULg et al

in Transplant International (2015, November), 28(S4), 1129

Experimental models of renal ischemia/reperfusion (I/R) have suggested protective effects of mesenchymal stromal cells (MSC) therapy. Still, param- eters of MSC injection, including volume, route and ... [more ▼]

Experimental models of renal ischemia/reperfusion (I/R) have suggested protective effects of mesenchymal stromal cells (MSC) therapy. Still, param- eters of MSC injection, including volume, route and timing of cell administration, remain largely debated. Particularly, MSC infusion in mouse has been shown to be beneficial “a priori” but deleterious “a posteriori” of renal I/R injury. In order to further investigate the influence of the timing of MSC administration, we used 10-week-old Lewis rats categorized in 4 groups. Groups 1 (MSC D-7, n = 10) and 2 (MSC D + 1, n = 7) received caudal i.v. injection of MSC (1.5 9 106 in 1 ml of saline) 7 days before or 1 day after renal I/R, respectively. Control groups 3 (saline D-7, n = 6) and 4 (saline D + 1, n = 6) received equal volume of saline at similar time points. Left renal ischemia (by clamping of the renal pedicle) lasted 45 min. Right nephrectomy was simultaneously performed. Blood sample was collected from inferior vena cava at 48 h post reperfusion. MSC phenotype was confirmed by FACS analysis. In groups 1 and 3, serum creatinine (SCr) reached 1.4 ` 0.7 versus 2.4 ` 0.8 mg/dl, respectively (p < 0.05). In groups 2 and 4, SCr was 4.9 ` 0.7 versus 3.3 ` 0.9 mg/dl, respectively (p < 0.001). Furthermore, SCr levels were statistically worse when MSC were administered after renal I/R in comparison to a priori infusion (p < 0.0001). In conclusion, MSC administration 7 days prior to renal I/R attenuates kidney injury in comparison to (i) saline infusion or (ii) MSC infusion 1 day after renal I/R. Conversely, on the basis of SCr levels, MSC therapy performed after renal I/R worsens kidney injury in rats. [less ▲]

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See detailIncreased risk of interstitial fibrosis and tubular atrophy in controlled donation after circulatory death kidney transplantation
WEEKERS, Laurent ULg; Ledinh, H; BONVOISIN, Catherine ULg et al

in Transplant International (2015, November), 28(S4), 49118

Introduction: Comparable transplant outcomes between controlled donation after circulatory death (cDCD) and donation after brain death (DBD) kidney transplantation (KT) have been confirmed. However, few ... [more ▼]

Introduction: Comparable transplant outcomes between controlled donation after circulatory death (cDCD) and donation after brain death (DBD) kidney transplantation (KT) have been confirmed. However, few data describes the histology of cDCD-KT which is subjected to prolonged procurement warm ischemia. This study aimed to evaluate the rate of interstitial fibrosis (IF) and tubular atrophy (TA) on the surveillance biopsy performed in our unit between the 2 and 6 months post KT. Acute rejection was considered as secondary endpoint. Patients and Methods: 330 KT (226 DBD and 104 DCD) have been performed between 2008 and 2014. Surveillance or per-cause biopsy was performed in 272 recipients. Among them, the rate of adequate (≥8 glomeruli and ≥1 large-sized artery) was 76.8%. Results: IFTA was found in 11.5% and 25.7% of DBD and cDCD-KT, respectively (p = 0.004). Considering IF and TA separately, the corresponding rates were 20.4% vs 32% (p = 0.04) and 23% vs 36% (p = 0.03), respectively. If acute rejection before routine biopsy was excluded, either IF or TA rate was significantly higher in cDCD- than DBD-KT (12.6% vs 27.1%, p = 0.006; 17.6% vs 31.4%, p = 0.016; and 20.9% vs 35.7%, p = 0.015 in case of IF-TA, IF, and TA, respectively). A cDCD-KT compared to a DBD-KT was 3.11 (95%CI 1.51– 6.43, p = 0.002), 2.34 (95%CI 1.21–4.53, p = 0.011) and 2.29 (95%CI 1.23– 4.27, p = 0.009) times more likely to have IFTA, IF, and TA, respectively. Extended criteria donor (ECD) vs standard criteria donor (SCD) was also an independent risk factor for IFTA (OR = 3.11, 95%CI 1.51–6.43, p = 0.002), IF (OR = 4.86, 95%CI 1.96–12.05, p = 0.001), and TA (OR = 4.09, 95%CI 1.68– 9.93, p = 0.002). The rate of acute rejection diagnosed by SB was 7.1% and 8.9% in DBD and cDCD kidney grafts (p = ns), respectively.Conclusion: KT from cDCD increased the risk of IF-TA between 3 and 6 months post-transplant. Further studies are warranted to investigate the evolution of this phenomenon over time and its effect on graft function. [less ▲]

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See detailA consecutive series of 100 controlled DCD liver transplantation
DETRY, Olivier ULg; DE ROOVER, Arnaud ULg; Ledinh, H et al

in Transplant International (2015, November), 28(S4), 109296

Introduction: Donation after circulatory death (DCD) have been proposed to partially overcome the organ donor shortage. DCD-LT remains controversial, with reported increased risk of graft loss and ... [more ▼]

Introduction: Donation after circulatory death (DCD) have been proposed to partially overcome the organ donor shortage. DCD-LT remains controversial, with reported increased risk of graft loss and retransplantation. The authors retrospectively reviewed a single centre experience with controlled DCD-LT in a 12-year period. Patients and Methods: 100 DCD-LT were consecutively performed between 2003 and 2014. All donation and procurement procedures were performed as controlled DCD in operative rooms. Data are presented as median (ranges). Median donor age was 57 years (16–83). Median DRI was 2.16 (1.4–3.4). Most grafts were flushed with HTK solution. Allocation was centre-based. Median recipient MELD score at LT was 15 (7–40). Mean follow-up was 35 months. No patient was lost to follow-up. Results: Median total DCD warm ischemia was 19 min (10–39). Median cold ischemia was 235 min (113–576). Median peak AST was 1132 U/l (282– 21 928). Median peak bilirubin was 28 mg/dL. Patient survivals were 90.7%, 75.5% and 70.7% at 1.3 and 5 years, respectively. Graft survivals were 88.7%, 72.1% and 67.1% at 1.3 and 5 years, respectively. Biliary complications included mainly anastomotic strictures and extrahepatic main bile duct ischemic obstruction, that were managed either by endoscopy or hepatico- jejunostomy. No PNF or graft loss due to ischemic cholangiopathy was observed in this series. Discussion: In this series, DCD LT appears to provide results similar to classical LT. Short cold ischemia and recipient selection with low MELD score may be the keys to good results in DCD LT, in terms of graft survival and avoidance of ischemic cholangiopathy. If symptomatic ischemic cholangiopa- thy is diagnosed, adequate management with endoscopy and surgical hepaticojejunostomy may avoid graft loss and retransplantation. [less ▲]

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See detailTransfusion needs during liver transplantation at the chu of liege (belgium): characteristics and preoperative predictive factors
PAGE, Isaline ULg; HANS, Grégory ULg; DETRY, Olivier ULg et al

in Transplant International (2015, November), 28(S4), 461272

Introduction: Liver transplantation (LT) can result in significant bleeding requiring transfusion of allogenic blood products, which potentially leads to postoperative morbidity and mortality (1). This ... [more ▼]

Introduction: Liver transplantation (LT) can result in significant bleeding requiring transfusion of allogenic blood products, which potentially leads to postoperative morbidity and mortality (1). This study aimed to determine transfusion needs during LT in our institution and its preoperative predictive factors. Material and Methods: Two hundred LT performed at the CHU Liege between 2006 and 2012 were respectively reviewed (age = 55 ` 11 yo, BMI = 25.5 ` 4.4 kg/m2, F/M = 45/155, MELD score = 19 ` 10). Transfu- sion needs of the different blood products during POD 0, and POD 0–7 were recorded. Parameters associated with the transfusion of more than 2 units of RBC (p ≤ 0.1) were identified using the Kruskal Wallis and chi square tests (table 1). These parameters were then placed into a backward stepwise logistic regression model for the transfusion of more than two units of RBC at POD 0. A p value threshold ≥0.1 was used for leaving the model. Results: Transfusion needs were: RBC = 2[0–4], FFP = 4[2–7], PLT = 1[0– 1] during POD 0; and RBC = 3[0–6], FFP = 6[3–10], PLT = 1[0–2] during POD 0–7. Preoperative factors independently associated with the transfusion of more than two units of RBC were preop Hb (0.6 [0.46–0.79], p < 0.001) and MELD score (1.13 [1.06–1.20], p < 0.001). Discussion: These results suggest that preop Hb and MELD score are associated with blood requirements during LT. [less ▲]

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See detailOrgan donation after euthanasia on specific patients' request in Belgium
Ysebaert, D; DETRY, Olivier ULg; Verfaillie, G et al

in Transplant International (2015, November), 28(S4), 114313

Euthanasia is since 2002 legalized in Belgium for adults under strict conditions. The patient must be in a medically futile condition, of constant and unbearable physical or mental suffering that cannot ... [more ▼]

Euthanasia is since 2002 legalized in Belgium for adults under strict conditions. The patient must be in a medically futile condition, of constant and unbearable physical or mental suffering that cannot be alleviated, resulting from a serious and incurable disorder caused by illness. This implies that also non-terminal not-cancer patients can request for euthanasia for instance in case of debilitating neurological disorder. From 2005 till 2015 more than 25 patients, suffering from diverse neuropsychiatric diseases, got their request for euthanasia granted, and subsequently asked spontaneously for the possibility of organ donation. The involved physicians, the transplant teams and the Institutional Ethics Commit- tees, had the well-discussed opinion that this strong request for organ donation after euthanasia could not be denied. A clear separation between the euthanasia request, the euthanasia procedure and the organ procurement procedure was judged necessary. After extensive preparation, finally, in Belgium, 17 patients got their wish for organ donation after euthanasia fulfilled, in several academic or non-academic hospitals and in different regions. Several requests and preparations were started for other patients but ultimately did not lead to organ donation due to patients’ personal choices or logistically reasons. The euthanasia procedure was carried out by three physicians involved in the euthanasia granting. After clinical diagnosis of cardiac death, the procurement team came in and performed the organ procurement similar as in a DCD type III procedure. Almost always, liver, two kidneys and sometimes lungs and pancreatic islets were successfully recovered and transplanted, after allocation by Eurotransplant. The possibility of organ donation after their euthanasia provides a very much improved self-image of these patients, and adds something really positive to the unfortunate end-of-life of these patients. [less ▲]

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See detailDonor Age in Liver Transplantation: Donation after Circulatory Death.
DETRY, Olivier ULg

in Journal of the American College of Surgeons (2015), 221(3), 779

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See detailShould ABO-incompatible deceased liver transplantation be reconsidered?
Detry, Olivier ULg

in Transplant international : official journal of the European Society for Organ Transplantation (2015), 28(7), 788-9

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See detailThird-party mesenchymal stem cell infusion in kidney transplant recipient: 6-month safety interim analysis
WEEKERS, Laurent ULg; ERPICUM, Pauline ULg; DETRY, Olivier ULg et al

in American Journal of Transplantation (2015, May), 15(suppl 3),

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See detailOrgan donation after euthanasia on specific patients' request in Belgium
Ysebaert, Y; DETRY, Olivier ULg; Mikhalski, D et al

Conference (2015, March 28)

Euthanasia is banned in almost countries of the world, although in 2002 Belgium legalized it for adults under strict conditions (in a similar way after The Netherlands in 2001. The patient must be in a ... [more ▼]

Euthanasia is banned in almost countries of the world, although in 2002 Belgium legalized it for adults under strict conditions (in a similar way after The Netherlands in 2001. The patient must be in a medically futile condition, of constant and unbearable physical or mental suffering that cannot be alleviated, resulting from a serious and incurable disorder caused by illness or accident. If the person is not in the terminal phase of his illness, the 2 doctors must consult with a third doctor, either a psychiatrist or a specialist in the disease concerned. From 2005 till 2014 more than 25 patients, suffering from diverse neuropsychiatric diseases, got their request for euthanasia granted, and subsequently asked spontaneously for the possibility of organ donation. The involved physicians, the transplant teams and the Institutional Ethics Committees, had the well-discussed opinion that this strong request for organ donation after euthanasia could not be denied. A clear separation between the euthanasia request, the euthanasia procedure and the organ procurement procedure was judged necessary. After extensive preparation, finally, in Belgium, 17 patients got their wish for organ donation after euthanasia fulfilled, in several academic or non-academic hospitals and in different regions : Antwerpen 6, Leuven 5, Liege 2, Namur 1, Turnhout 1, and Brussels 2. Several requests and negotiations were started for other patients but ultimately failed due to patients’ personal choices (e.g. patient wanted finally to die at home) or logistically reasons (e.g. who would fulfil the euthanasia in case all involving doctors were not employed or connected to a hospital). The euthanasia procedure was carried out by three physicians in the neighborhood of the operating room. After clinical diagnosis of cardiac death, the procurement team came in and performed the organ procurement similar as in a DCD type III procedure. The liver, two kidneys and sometimes lungs and pancreatic islets could be successfully recovered and transplanted, after organ allocation via Eurotransplant. Transplant centers were informed about the nature of the case and the elements of organ procurement. There was primary function of all organs. The possibility of organ donation after their euthanasia provides a very much improved self-image of these patients, and adds something really positive to the euthanasia procedure, and is very well appreciated by the requesting patients, relatives, patient and professional organisations and public media. Some practical and ethical issues still have to be discussed to allow expansion of this possibility of organ donation. [less ▲]

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See detailInfusion of third-party mesenchymal stromal cells after liver transplantation: a phase 1, open-label, clinical study
DETRY, Olivier ULg; VANDERMEULEN, Morgan ULg; DELBOUILLE, Marie-Hélène ULg et al

Poster (2015, March 27)

Transplanted patients have to deal with numerous side effects of life-long dependence on immunosuppressive drugs. Paradoxically these drugs fail to prevent acute and/or chronic rejection in many cases ... [more ▼]

Transplanted patients have to deal with numerous side effects of life-long dependence on immunosuppressive drugs. Paradoxically these drugs fail to prevent acute and/or chronic rejection in many cases. Mesenchymal stromal cells (MSC) are multipotent and self-renewing bone marrow progenitors that have been shown both in vitro and in vivo as capable of (i) immunomodulation, (ii) anti-inflammation in case of ischemia/reperfusion injury, and (ii) stimulation of tissue repair. MSC could therefore be very interesting in organ recipients to limit chronic graft damage and to allow tolerance. This study aimed to be the first clinical evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled, phase I study. Clinical grade MSCs were locally collected from the bone marrow of unrelated healthy donors. They were cultured in a GMP-compliant lab, underwent extensive quality controls and were frozen for storage in a MSC bank. When needed for patient treatment, MSC were thawed and intravenously injected into patients. 10 liver transplant recipients under standard immunosuppression (TAC-MMF-low dose steroids until day 30) received 1.5-3x106/kg MSC on post- operative day 3 ± 2. These patients were prospectively compared to a group of 10 control (MSC-) liver recipients. Primary endpoints were MSC infusion toxicity, and incidence of cancer and opportunistic infections at month 6. Secondary endpoints were patient and graft survivals and rejection at month 6, as well as the effects of MSC on recipients’ immune function and on immunohistology of at month 6 graft biopsies. No MSC infusional toxicity was observed. Both groups were comparable in terms of donor and recipient characteristics. There was no difference in primary end-points between control and MSC groups. No patient developed de novo cancer. There was no statistical difference in patient and graft survivals or in rejection rates. There was no graft rejection in the MSC group. Month-6 graft biopsies were not different according to Banff and fibrosis scores. This phase I study showed excellent tolerability and safety of a single infusion of third-party MSC after liver transplantation. There were no graft safety issues and no excess of immunosuppression after MSC injection. Further analyses of consequences of MSC injection on the immune profile are needed. The possibility of avoiding calcineurin-inhibitors with repeated MSC injections as main immunosuppressive therapy and/of tolerance induction by MSC infusion should be investigated by further studies. [less ▲]

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See detailPrognostic value of (18)F-FDG PET/CT in liver transplantation for hepatocarcinoma.
Detry, Olivier ULg; Govaerts, Laurence; De Roover, Arnaud ULg et al

in World journal of gastroenterology : WJG (2015), 21(10), 3049-54

AIM: To evaluate the prognostic value of pretreatment FDG positron emission tomography computed tomography (PET-CT) in patients with hepatocarcinoma treated by liver transplantation (LT). METHODS: The ... [more ▼]

AIM: To evaluate the prognostic value of pretreatment FDG positron emission tomography computed tomography (PET-CT) in patients with hepatocarcinoma treated by liver transplantation (LT). METHODS: The authors retrospectively analyzed the data of 27 patients (mean age 58 +/- 9 years) who underwent FDG PET-CT before LT for hepatocarcinoma. Mean follow-up was 26 +/- 18 mo. The FDG PET/CT was performed according to a standard clinical protocol: 4 MBqFDG/kg body weight, uptake 60 min, low-dose non-enhanced CT. The authors measured the SUVmax and SUVmean of the tumor and the normal liver. The tumor/liver activity ratios (RSUVmax and RSUVmean) were tested as prognostic factors and compared to the following conventional prognostic factors: MILAN, CLIP, OKUDA, TNM stage, alphafoetoprotein level, portal thrombosis, size of the largest nodule, tumor differentiation, microvascular invasion, underlying cirrhosis and liver function. RESULTS: Overall and recurrence free survivals were 80.7% and 67.4% at 3 years, and 70.6% and 67.4% at 5 years, respectively. According to a multivariate Cox model, only FDG PET/CT RSUVmax predicted recurrence free survival. Even though the MILAN criteria alone were not predictive, it is worth noting that none of the patients outside the MILAN criteria and with RSUVmax < 1.15 relapsed. CONCLUSION: FDG PET/CT with an RSUVmax cut-off value of 1.15 is a strong prognostic factor for recurrence and death in patients with HCC treated by LT in this retrospective series. Further prospective studies should test whether this metabolic index should be systematically included in the preoperative assessment. [less ▲]

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See detailInfusion of third-party mesenchymal stream cells after liver transplantation: a phase-1, open-label, clinical study
DETRY, Olivier ULg; VANDERMEULEN, Morgan ULg; DELBOUILLE, Marie-Hélène ULg et al

in Acta Gastro-Enterologica Belgica (2015, March), 78(1), 29

Background: Mesenchymal stromal cells (MSC) are multipotent bone marrow progenitors that have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aimed ... [more ▼]

Background: Mesenchymal stromal cells (MSC) are multipotent bone marrow progenitors that have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aimed to be the first evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled phase-1 study. This study aimed to be the first evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled phase-1 study. Patients & Methods: Clinical grade MSCs were locally collected from the bone marrow of unrelated healthy donors. They were cultured in a GMP-compliant lab, underwent extensive quality controls and were frozen for storage in a MSC bank. When needed for patient treatment, MSC were thawed and intravenously injected into patients. 10 liver transplant recipients under standard immunosuppression (TAC-MMF-low dose steroids until day 30) received 1.5-3x106/kg MSC on post-operative day 3±2. These patients were prospectively compared to a group of 10 control (MSC-) liver recipients. Primary endpoints were MSC infusion toxicity, and incidence of cancer and opportunistic infections at month 6. Secondary endpoints were patient and graft survivals and rejection at month 6, as well as the effects of MSC on recipients’ immune function and on immunohistology of at month 6 graft biopsies. Results: No MSC infusional toxicity was observed. Both groups were comparable in terms of donor and recipient characteristics. There was no difference in primary end-points between control and MSC groups. No patient developed de novo cancer. There was no statistical difference in patient and graft survivals or in rejection rates. There was no graft rejection in the MSC group. Month-6 graft biopsies were not different according to Banff and fibrosis scores. Discussion: This phase 1 study showed excellent tolerability and safety of a single infusion of third-party MSC after liver transplantation. There were no graft safety issues and no excess of immunosuppression after MSC injection. Further analyses of consequences of MSC injection on the immune profile are needed. The possibility of avoiding calcineurin-inhibitors with repeated MSC injections as main immunosuppressive therapy and/of tolerance induction by MSC infusion should be investigated by further studies. [less ▲]

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See detailExpel: a novel non-destructive method for mining soluble tumor biomarkers
Costanza, B; Blomme, A; MUTIJIMA NZARAMBA, Eugène ULg et al

in Acta Gastro-Enterologica Belgica (2015, March), 78(1), 13

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See detailMetabolomic, proteomic and preclinical imaging of patient-derived tumor xenografts for improving treatment of liver metastases patients
Perez Palacios, A; Blomme, A; Boutry, S et al

in Acta Gastro-Enterologica Belgica (2015, March), 78(1), 134

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