HAIFA, Israel, Nov. 7, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today the Company has successfully completed the integration and testing of its new scaled-up formulation and manufacturing process to produce high-yield quantities of its Placental eXpanded (PLX) cells for clinical trials and potential commercial use. The increased automation and larger scale process allows the company to produce billions of live cells simultaneously. As part of its manufacturing process, Pluristem has optimized growth conditions to maximize yields with lower costs. The company has minimized open manipulation steps in order to improve the aseptic quality and safety of the product. Critical steps have been automated including the process of harvesting and purification; the integration of closed system washing and concentration steps, and the product's final packaging has been changed to an aseptically automated vial system. In the past 15 months, Pluristem has invested resources and efforts to develop technologies resulting in an efficient, cutting edge production line. All of the integrated changes have been tested and will be integrated into Pluristem's new production site in Israel. Pluristem recently announced it is in the final steps of building out its new manufacturing … Continue reading →

Washington, November 7 (ANI): Stem cell therapy improves heart function in patients who had previous heart attacks, according to researchers from the University of Louisville and Brigham and Women's Hospital. In a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2012 meeting, Roberto Bolli, M.D., of the University of Louisville and Piero Anversa, M.D., of Brigham and Women's Hospital, Boston, presented data from their groundbreaking research in the use of autologous adult stem cells with patients who had previous heart attacks. They report that after two years, all patients receiving the stem cell therapy show improvement in heart function, with an overall 12.9 absolute unit increase in left ventricular ejection fraction (LVEF), a standard measure of heart function that shows the amount of blood ejected from the left ventricle during a heartbeat. No adverse effects resulting from the therapy were seen. Moreover, MRIs performed on nine patients in the trial showed evidence of myocardial regeneration - new heart tissue replacing former dead tissue killed by heart attack. "The trial shows the feasibility of isolating and expanding autologous stem cells from virtually every patient," said Bolli, who is the Jewish Hospital Heart and Lung Institute Distinguished Chair in … Continue reading →

Published on 10 November 2012 Hits: 70 Written by Jovee Marie N. Dela Cruz The Department of Health (DOH) on Friday said that it has become necessary to issue regulations for stem cell therapy in the country. Health Secretary Enrique Ona said that guidelines for clinics offering stem cell therapy will be released immediately by the DOH and the Food and Drug Administration. We will issue guidelines because here in the country we dont know where the stem cell offered by clinics come from, he said. According to the DOH, stem cell therapy belongs to the category of advanced cell therapy, which includes biologics and blood. Many countries apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy. In many countries, stem cell is considered an investigational intervention, Ona said. The DOH said that stem cell research employs both autologous (from same person) or allogenic (from another organism like an animal or another human cell or tissue sample) method. Ona said that because there are many steps in the preparation of this lab and invasive procedure, there is a need to have a regulatory framework to protect Filipino citizens. Read this article: DOH to regulate … Continue reading →

April Flowers for redOrbit.com Your Universe Online Conflicting studies were highlighted at this years American Heart Association Scientific Sessions meeting concerning stem cell therapy for heart attack patients. The first study, from the University of Louisville and Brigham and Womens Hospital, reported holy grail results for a Phase I clinical trial: marked sustained improvement in all patients with zero adverse effects. Roberto Bolli, M.D., of the University of Louisville and Piero Anversa, M.D., of Brigham and Womens Hospital presented data from their groundbreaking research in the use of autologous adult stem cells with patients who had previous heart attacks in a Late-Breaking Clinical Trial session. The researchers report that all patients receiving the stem cell therapy showed improved heart function after two years, with an overall 12.9 absolute unit increase in left ventricular ejection fraction (LVEF). LVEF is a standard measure of heart function that shows the amount of blood ejected from the left ventricle during a heartbeat. They saw no adverse effects from the therapy. In fact, nine patients showed evidence of myocardial regeneration new tissue replacing formerly dead tissue killed by heart attack in MRI scans. The trial shows the feasibility of isolating and expanding autologous stem cells … Continue reading →

UPDATE on Stem Cell Therapy 7 November 2012 The Department of Health (DOH) saw the necessity to cover regulations for Stem Cell therapy. Stem Cell therapy belongs to the category of Advanced Cell therapy which includes biologics and blood. Many countries around the world apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy. In many countries, Stem Cell is considered an investigational intervention. Stem Cell research employs both autologous (from same person) or allogenic (from another organism like animal or another human cell or tissue sample) method. Because there are many steps in the preparation of this lab and invasive procedure, there is therefore need to have a regulatory framework to protect Filipino citizens. Important questions were asked: is there proof of concept in animal trials where stem cell can then be applied in humans? Is there a way to ensure quality and purity of the raw materials? How safe is the procedure? How many did not benefit from the procedure? If this were investigational procedure, how will human subjects be protected? Sec. Enrique Ona convened a consultative working task force to provide recommendations on how to proceed in the early part of the … Continue reading →