Showing posts with label Clinical trial. Show all posts
Showing posts with label Clinical trial. Show all posts

Saturday, March 27, 2010

National Institutes of Health - Clinical Cente...Image via Wikipedia

One of the better-kept secrets about the massive clinical research hospital at the National Institutes of Health (NIH) in Bethesda, Md., has been tucked away for half a century in Wing D of a building that dates to 1953. That is about to change.

The Pharmaceutical Development Section (PDS) is a corps of 20 chemists, pharmacists, pharmacokineticists and technicians who make investigational agents for many of the 1,500 clinical research studies running at any given moment at the NIH's Clinical Center. It is not a drug-discovery group, but rather a team of experts who churn out custom-made pills, vaccines, intravenous drugs and capsules, and even ointments and creams, for NIH investigators when the investigational agents they need aren't available.

Twenty-first century technology and government-mandated manufacturing standards have outpaced the equipment and capacities of the group's old, 743-square-metre workspace. But, if all goes according to schedule, in early June it will move seamlessly into a new, $12-million, 1,115-square-meter drug-making facility--a warren of rooms seven years in the planning that is tailor-made for the group's purposes.

The PDS's new digs are a reservoir of state-of-the-art machinery and minus 80 ÂșC freezers; high-efficiency particulate-absorbing filters populate the ceiling; and highly purified watercirculates through stainless-steel pipes that cost over $1,000 per meter. There are meticulous controls on air temperature, humidity and pressure. The facility's layout and structural materials are geared to maximum cleanliness--right down to the easily-scoured, porous epoxy floors."

Nature

Saturday, March 13, 2010

University of Miami Stem Cell Success

Leonard M.Image via Wikipedia

Using Stem Cells in Teatment for Heart Attacks

MIAMI- Dramatic findings have been released by a University of Miami Miller School of Medicine researcher on the first human clinical trial to test a stem-cell based treatment for heart attack patients. The phase one trial was designed to determine the safety and efficacy of infusing adult human mesenchymal stems cells intravenously in patients within days of a myocardial infarction, or heart attack, to lessen damage to the heart muscle.

Fifty-three patients, who had suffered a first heart attack within one to ten days, were enrolled at ten medical centers across the United States beginning in February 2005. In the trial, sponsored by Osiris Therapeutics of Baltimore, Maryland which provided the cells, patients were randomized to one of three doses of stem cells, and each dose was compared with placebo. The occurrence of treatment-related serious adverse events was evaluated at six months, and efficacy was assessed using echocardiography.

“Over the six month follow-up period the stem cell treated patients had lower rates of side effects such as cardiac arrhythmias, and they had significant improvements in heart, lung and global function,” said Joshua Hare, M.D., professor of medicine, director of the Interdisciplinary Stem Cell Institute at the Miller School of Medicine, and lead author and principal investigator for the entire study. “Echocardiography showed improved heart function, particularly in those patients with large amounts of cardiac damage.”

The study findings were presented today at the American College of Cardiology’s Innovation in Intervention: i2Summit being held in New Orleans.

“This trial offers a distinct advancement in the field of stem cell-based treatments by providing safety and efficacy data for a unique and promising type of stem cell to treat cardiac damage,” said Dr. Hare. “It’s important to note that this study is very early, and, as in other disease categories, we must expand trials to determine the real world application of stem cell therapy to fight heart disease.”

As a cell-based therapy, mesenchymal stem cells have a number of unique advantages: they can be taken from genetically distinct donors, are easy to prepare, and have a tendency to collect within injured areas. In animal models, this type of stem cell not only homes to regions of cardiac damage, but reduces the infarct size and improves ejection function – the portion of blood that is punted out of the heart as a result of a heartbeat, and a primary indicator of the heart’s health.

This year an estimated 700,000 Americans will suffer a heart attack, and despite the best care many will go on to develop congestive heart failure from the muscle damage caused by the heart attack. The promise of stem cell therapy in reversing or preventing that damage provides a significant benefit in an area of unmet medical need.