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Gene Therapy Clinical Trial Gets Underway for Heart Failure Patients
The first phase of a gene therapy clinical trial has been completed and the second phase of the trial, which is attempting to treat patients suffering from advanced heart failure is underway and, apparently, already offering positive results, according to news reports.
The trial, which is known as the Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID), is being lead by physicians with the New York-Presbyterian Hospital/Columbia University Medical Center, who are studying the patients’ reaction to receiving the gene therapy drug. According to results from Phase I of the study, which was conducted to determine safe dosage ranges and determine drug side effects, found that seven of the nine patients involved "showed improvements over six months."
Phase II of the study has expanded the number of patients involved as well as created a "randomized, double-blind, placebo-controlled clinical trial that will compare the therapy at two or three dose levels with a placebo," according to a Science Daily news article explaining the trial. Approximately 46 individuals are to enroll at 13 hospitals across the United States in Phase II.
What is Gene Therapy?
The National Library of Medicine (NLM) explains that gene therapy is "an experimental technique that uses genes to treat or prevent disease by inserting a gene into a patients cells instead of using drugs or surgery."
The NLM also reports that there are a variety of methods used in gene therapy including the following:
* Replacement of a mutated gene with that of a healthy gene copy. * If a mutated gene is "improperly functioning" gene therapy can be administered by inactivating the gene. * To help the body fight a disease, the introduction of a new gene can be administered.
Heart Failure Causes
According to the Science Daily news article there are approximately 5 million individuals currently living with heart failure and heart disease conditions that puts them at ri
sk for severe injury or death each day. Additionally, the article reported that "heart failure is the only cardiovascular disease whose incidence has been increasing rather than decreasing in recent years."
There are a number of factors that are related to the development of heart disease or heart failure among patients. According to the American Heart Association (AHA) the following are potential factors and medical conditions that may affect the development of such a disease. These factors can include:
Additionally, one of the newest causes for heart failure and heart disease is actually a man-made cause, which is the development of prescription drugs that pose a risk to one’s health.
Pharmaceutical Dangers
Of the pharmaceutical dangers that may increase the potential for an individual developing heart disease is that of Avandia. Avandia is a type 2 diabetes drug that was released in May 1999 from GlaxoSmithKline and had been prescribed to millions of diabetic patients. Avandia, part of a newer class of medications, including Actos, was linked in a 2007 New England Journal of Medicine article to the development of heart failure among diabetic patients whose risk for developing the heart failure is increased because of their diabetic condition.
Individuals who suffered from the Avandia side effects should speak with their medical professional regarding changing or altering medications. Additionally, speaking to a pharmaceutical attorney may provide the necessary legal assistance for an individual to obtain monetary compensation in regards to their suffering from dangerous Avandia risks.
Peter Kent is the best-selling author of 50 books and hundreds of articles for magazines and newspapers. He manages Legalview.com, a website hosting a variety of information on legal issues, including Avandia.
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