Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial)

Background and Objectives@#The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients with chronic ischemic cardiomyopathy (CIC). The trial aimed to assess (i) the safety and the efficacy of cell transplantation during one-year follow-up, (ii) to compare the efficacy of HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs) in the same clinical settings. @*Methods@#and Results: Fifty-four patients who were randomized to receive HUC-MSCs (23×106) (n=26) or BM-MNCs (70×107) (n=12) in combination with CABG surgery. The control patients (n=16) received no cells/vehicles but CABG intervention. All patients were screened at baseline and 1, 3, 6, 12 months after transplantation. Forty-six (85%) patients completed 12 months follow-up. No short/mid-term adverse events were encountered. Decline in NT-proBNP (baseline∼ 6 months) in both cell-treated groups; an increase in left ventricular ejection fraction (LVEF) (5.4%) and stroke volume (19.7%) were noted (baseline∼6 or 12 months) only in the HUC-MSC group. Decreases were also detected in necrotic myocardium as 2.3% in the control, 4.5% in BM-MNC, and 7.7% in the HUC-MSC groups. The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups. @*Conclusions@#Significant findings directly related to the intramyocardial delivery of HUC-MSCs justified their efficacy in CIC. Stricter patient selection criteria with precisely aligned cell dose and delivery intervals, rigorous follow-up by detailed diagnostic approaches would further help to clarify the responsiveness to the therapy.

Lipid accumulation product is a predictor of nonalcoholic fatty liver disease in childhood obesity / 소아과

BACKGROUND: Lipid accumulation product (LAP) is associated with the presence and severity of nonalcoholic fatty liver disease (NAFLD) in adults.PURPOSE: Here we evaluated the ability of LAP to predict NAFLD in obese children.METHODS: Eighty obese children (38 girls; age 6–18 years) were included. Anthropometric measurements and biochemical values were obtained from the patients’ medical records. LAP was calculated as [waist circumference (WC) (cm) – 58]×triglycerides (mmol/L) in girls; [WC (cm) – 65]×triglycerides (mmol/L) in boys. The minLAP and adjLAP were described (3% and 50% of WC values, respectively) and the total/high-density lipoprotein cholesterol index (TC/HDL-C) was calculated. NAFLD was observed on ultrasound, and patients were divided into 3 groups by steatosis grade (normal, grade 0; mild, grade 1; moderate-severe, grade 2–3). The area under the curve (AUC) and appropriate index cutoff points were calculated by receiver operator characteristic analysis.RESULTS: LAP was positively correlated with puberty stage (rho=0.409; P<0.001), fasting insulin (rho=0.507; P<0.001), homeostasis model assessment of insulin resistance (rho=0.470; P<0.001), uric acid (rho=0.522; P<0.001), and TC/HDL-C (rho=0.494; P<0.001) and negatively correlated with HDL-C (rho=-3.833; P<0.001). LAP values could be used to diagnose hepatosteatosis (AUC=0.698; P=0.002). The LAP, adjLAP, and minLAP cutoff values were 42.7 (P=0.002), 40.05 (P=0.003), and 53.47 (P=0.08), respectively. For LAP, the differences between the normal and mild groups (P=0.035) and the normal and moderate-severe groups were statistically significant (P=0.037), whereas the difference between the mild and moderate-severe groups was not (P>0.005). There was a statistically significant difference between the normal and mild groups for adjLAP (P=0.043) but not between the other groups (P>0.005). There was no significant intergroup difference in minLAP (P>0.005).CONCLUSION: LAP is a powerful and easy tool to predict NAFLD in childhood. If LAP is ≥42.7, NAFLD should be suspected. This is the first study to assess LAP diagnostic accuracy for childhood obesity.

relationship between markedly elevated glucose challenge test results and the rate of gestational diabetes mellitus and gestational impaired glucose tolerance

Even though the 50 g oral glucose challenge test [GCT] is the most commonly used screening modality for gestational diabetes mellitus [GDM], no consensus for the diagnostic approach is available to patients with a markedly elevated GCT result. We aimed to evaluate the diagnostic utility of markedly elevated GCT results and the impact of age using the oral glucose tolerance test [OGTT] as gold standard. Retrospective study conducted in a women's hospital in Ankara, among patients who underwent GCT from January 2005 to December 2008. In this retrospective study, we included 626 pregnant women who underwent a 3-hour 100 g OGTT after a GCT result >/= 180 mg/dL among 29 842 women. We calculated positive predictive values [PPV] of each GCT category to diagnose GDM and both GDM and gestational impaired glucose tolerance [GIGT]. A GCT result of >/= 240 mg/dL provided 100% PPV for the diagnosis of GDM and a result of >230 mg/ dL provided 100% PPV for the diagnosis of GDM + gestational impaired glucose tolerance [GIGT], according to both, National Diabetes Data Group [NDDG] and Carpenter and Coustan [CC] criteria. A result of >/= 200 mg/dL provided 100% PPV for diagnosing GDM+GIGT in patients older than 35 years, according to the CC criteria. The GCT result of 200 mg/dL is an ideal cutoff value for the diagnosis of GDM + GIGT in patients >/= 35years, and OGTT can be omitted in these patients. In younger patients, the cutoff value should be chosen as 230 mg/dL