Intracoronary infusion of Wharton's jelly-derived mesenchymal stem cells in acute myocardial infarction: double-blind, randomized controlled trial.

BACKGROUND: The use of adult stem cells is limited by the quality and quantity of host stem cells. It has been demonstrated that Wharton's jelly-derived mesenchymal stem cells (WJMSCs), a primitive stromal population, could integrate into ischemic cardiac tissues and significantly improve heart function. In this randomized, controlled trial, our aim was to assess the safety and efficacy of intracoronary WJMSCs in patients with ST-elevation acute myocardial infarction (AMI). METHODS: In a multicenter trial, 116 patients with acute ST-elevation MI were randomly assigned to receive an intracoronary infusion of WJMSCs or placebo into the infarct artery at five to seven days after successful reperfusion therapy. The primary endpoint of safety: the incidence of adverse events (AEs) within 18 months, was monitored and quantified. The endpoint of efficacy: the absolute changes in myocardial viability and perfusion of the infarcted region from baseline to four months, global left ventricular ejection fraction (LVEF) from baseline to 18 months were measured using F-18-fluorodeoxyglucose positron emission computed tomography (F-18-FDG-PET) and 99mTc-sestamibi single-photon emission computed tomography (99mTc-SPECT), and two-dimensional echocardiography, respectively. RESULTS: During 18 months follow-up, AEs rates and laboratory tests including tumor, immune, and hematologic indexes were not different between the two groups. The absolute increase in the myocardial viability (PET) and perfusion within the infarcted territory (SPECT) was significantly greater in the WJMSC group [6.9 ± 0.6 % (95 %CI, 5.7 to 8.2)] and [7.1 ± 0.8 % (95 %CI, 5.4 to 8.8) than in the placebo group [3.3 ± 0.7 % (95 %CI, 1.8 to 4.7), P <0.0001] and 3.9 ± 0.6(95 %CI, 2.8 to 5.0), P = 0.002] at four months. The absolute increase in the LVEF at 18 months in the WJMSC group was significantly greater than that in the placebo group [7.8 ± 0.9 (6.0 to approximately 9.7) vs. 2.8 ± 1.2 (0.4 to approximately 5.1), P = 0.001]. Concomitantly, the absolute decreases in LV end-systolic volumes and end-diastolic volumes at 18 months in the WJMSC group were significantly greater than those in the placebo group (P = 0.0004, P = 0.004, respectively). CONCLUSIONS: Intracoronary infusion of WJMSCs is safe and effective in patients with AMI, providing clinically relevant therapy within a favorable time window. This study encourages additional clinical trials to determine whether WJMSCs may serve as a novel alternative to BMSCs for cardiac stem cell-based therapy. TRIAL REGISTRATION: Clinical Trials NCT01291329 (02/05/2011).

Vitamin D, parathyroid hormone and risk factors for coronary artery disease in an elderly Chinese population.

AIMS: Low vitamin D status has been shown to be associated with coronary artery disease; most studies have involved in adults, but few have involved elderly people. We planned to research the association between vitamin D, parathyroid hormone (PTH) and coronary artery disease in elderly people. METHODS: A population-based study was conducted among 1245 Chinese participants, aged 60-102 years, in the spring of 2013. Serum 25-hydroxyvitamin D (25 (OH)D) was measured by chemiluminescence assay. The levels of PTH were measured by the electrochemiluminescence immunoassay (ECLIA) method. RESULTS: One thousand two hundred and forty-five participants, including 543 women (43.6%), were evaluated in 2013. The median concentrations of serum 25 (OH)D and PTH for the entire group were 16.8 ng/ml and 41.0 pg/ml, respectively. The prevalence rates of diabetes, hypertension, hyperlipidemia and coronary artery disease were significantly different across the 25 (OH)D quartiles. The prevalence rates of diabetes, hypertension, hyperlipidemia and coronary artery disease were also significantly different across the PTH quartiles. In logistic regression analyses, serum 25 (OH)D levels were associated with risk of coronary artery disease in single and multiple regression models (P < 0.05). Serum PTH levels were also associated with the risk of coronary artery disease in single and multiple regression models (P < 0.05). Subgroup analyses stratified by sex or age yielded similar results. CONCLUSIONS: Serum vitamin D and PTH levels are independently associated with risk of coronary artery disease in a Chinese elderly population.