SHENZHEN, China, July 21, 2015 /PRNewswire/ -- On July 15th of 2015, Beike Biotechnology Co., Ltd. alongside leading Chinese hospitals and universities published new research utilizing Wharton's Jelly derived mesenchymal stem cells as a safe and effective treatment for acute myocardial infarction, more commonly known as heart attack. This double-blind, randomized controlled trial used intracoronary infusion as a delivery method for the adult stem cells produced by Beike Biotechnology. Wharton's Jelly is derived from umbilical cord tissue, the main source of Beike's mesenchymal stem cell products.
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).
In a multicenter, double-blind, randomized controlled 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.
During 18 months of 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 than in the placebo group 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. 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.
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 umbilical cord-derived mesenchymal stem cells may serve as a novel alternative to bone marrow stem cells for cardiac stem cell-based therapy.
Beike Biotechnology is the world's largest stem cell provider focusing on the research, product development, and clinical translation of adult stem cells as well as immunotherapy and anti-aging. For more information please visit www.beikebiotech.com.
SOURCE Beike Biotechnology Co. Ltd.