By Bruce Japsen, Tribune staff reporter
A treatment that uses adult stem cells to rebuild failing hearts--once believed to be impossible--will undergo a pivotal test starting this week in a 150-patient clinical trial under the watch of Baxter International Inc.
On Tuesday the Deerfield-based medical products giant is expected to announce the launch of the first U.S.-approved phase II study of adult stem cells to create new blood vessels in the cardiovascular system. The phase II study--a second, larger and more detailed experiment allowed after basic safety is established--is designed to investigate whether injecting adult stem cells directly into the heart can help patients rebound from severe coronary artery disease.
The first trial of just 24 patients was impressive enough to allow Baxter to move on to the second of three phases typically required by the U.S. Food and Drug Administration. In the first phase, most patients needed to take fewer nitrate tablets and could resume routine activities such as walking or retrieving the mail--tasks they were unable to do before the trial began.
A successful trial could put Baxter in the lead in U.S. development of a potentially lucrative business. Heart disease is the single leading cause of death in America, responsible for an estimated one in every five deaths.
Successful treatment could have profound impact
Two years ago, Ronald Trachtenberg said, the severe heart condition that hounded him for more than 20 years essentially had confined him to his recliner. Within six months of having his own stem cells injected into damaged areas of his heart, the 60-year-old retired accountant said, he began feeling like a new man. (Ronald Trachtenberg lives at 147 Center Street, YarmouthPort)
Today Trachtenberg reports dramatic reductions both in chest pain and in the need for the nitrate pills he previously took by the handful on days he had severe heart spasm. He said he can walk 500 feet back and forth in front of his Cape Cod, Mass., home and takes a nitrate pill, a common medication for people suffering severe angina, just "once in a blue moon."
"I used to be a frequent flier in the ambulance," said Trachtenberg, who had his first bypass operation at age 34, and another at 39, before he was so ill he was forced to sell his accounting firm in 1992.
In 2004 Trachtenberg was among 24 people in a randomized initial clinical trial in which his own stem cells were injected into his heart.
Trachtenberg said in a telephone interview Monday he believes the treatment helped him and has potential for others.
"This will be on the same level as the Salk and Sabin polio research. . . . This is going to save more people who have not had a chance," he said... Read the rest of this Chicago Tribune story here, and comment below.