14 research outputs found
Low-income minority mothers\u27 reports of infant health care utilisation compared with medical records
No full textReducing psychosocial and behavioral pregnancy risk factors: results of a randomized clinical trial among high-risk pregnant african american women
No full textPregnancy intendedness, happiness, maternal risk and their correlates during the first and second trimester of pregnancy
No full textSmoking during pregnancy, the tip of an iceberg: Associated behavioral risks and reproductive morbidities
No full textFactors associated with intimate partner violence during pregnancy in minority populations
No full textPrediction of Birth Weight By Cotinine Levels During Pregnancy in a Population of Black Smokers
No full textThe effect of a parenting education program on the use of preventive pediatric health care services among low-income, minority mothers: A randomized, controlled study
No full text
An Intervention to Reduce Environmental Tobacco Smoke Exposure Improves Pregnancy Outcomes
No full textDose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study)
No full textRATIONALE: Cell dose and concentration play crucial roles in phenotypic responses to cell-based therapy for heart failure. OBJECTIVE: To compare the safety and efficacy of two doses of allogeneic bone marrow-derived human mesenchymal stem cells (hMSC) identically delivered in patients with ischemic cardiomyopathy (ICM). METHODS AND RESULTS: Thirty patients with ICM received in a blinded manner either 20 million (20M, n=15) or 100 million (100M, n=15) allogeneic hMSCs via transendocardial injection (10 0.5 cc injections/patient). Patients were followed for 12-months for safety and efficacy endpoints. There were no treatment-emergent serious adverse events (SAE) at 30 days or treatment related SAEs at 12 months. The Major Adverse Cardiac Event rate was 20.0% (95% CI, 6.9%, 50.0%) in 20M and 13.3% (95% CI, 3.5%, 43.6%) in 100M (p=0.58). Worsening heart failure re-hospitalization was 20.0% (95% CI, 6.9%, 50.0%) in 20M and 7.1% (95% CI, 1.0%, 40.9%) in 100M (p=0.27). Whereas scar size reduced to a similar degree in both groups: 20M by −6.4g (IQR, −13.5g, −3.4g, p=0.001) and 100M by −6.1g (IQR, −8.1g, −4.6g, p=0.0002), the ejection fraction (EF) improved only with 100M by 3.7 units (IQR, 1.1, 6.1, p=0.04). NYHA class improved at 12 months in 35.7% (95% CI, 12.7%, 64.9%) in 20M and 42.9% (95% CI, 17.7%, 71.1%) in 100M. Importantly, pro-BNP increased at 12 months in 20M by 0.32 log pg/mL (95% CI, 0.02, 0.62, p=0.039), but not in 100M (−0.07 log pg/mL; 95% CI, −0.36, 0.23, p=0.65; between group p=0.07). CONCLUSION: Although both cell doses reduced scar size, only the 100M dose increased EF. This study highlights the crucial role of cell dose in the responses to cell therapy. Determining optimal dose and delivery is essential to advance the field, decipher mechanism(s) of action, and enhance planning of pivotal Phase III trials. CLINICAL TRIAL REGISTRATION: NCTO2013674 [https://clinicaltrials.gov/ct2/show/NCT02013674
