Augusta University part of stem-cell study for heart failure treatment
By Tom Corwin
Staff Writer
Sunday, April 24, 2016
Ever since he took part in a clinical research study two years ago at Augusta Uni*ver*sity where he either got stem cells or a placebo, Gene Gray has been looking for signs that might clue him in.
Gene Gray took part in a trial that looked at using stem cells to treat heart failure patients. He was given a placebo but now has the chance to receive the treatment.
“I’ve had good things happen to my heart so I thought I might have got them, and I’ve had bad things happen to my heart so I thought I might not have got them,” he said.
It turns out he got the placebo, but he has the opportunity to come back and get the real thing, which he plans to do soon.
The 52-year-old Augustan was one of 109 patients to take part in the largest clinical trial to look at using the cells as a potential treatment for heart failure patients. The study was a double-blind randomized control trial, meaning neither the patients nor the physicians injecting the cells into their hearts know whether it was the therapy or a placebo, a necessary step to avoid bias clouding the results.
“The strength of the study was really that it was randomized and it was double-
blinded,” said Dr. Adam Ber*man, a cardiologist and associate professor of medicine at AU who enrolled five patients including Gray into the trial.
And it showed results. There was a 37 percent reduction in the number of events patients suffered in the cell therapy versus those who got the placebo. This happened despite one of the critical measures studied in heart failure patients, the ability of the heart to send out blood, not improving any better in the therapy group versus the placebo.
“And yet we saw better outcomes with the cell therapy group,” Berman said.
What might be happening is a “paracrine response,” where the cells sent signals to the nearby ailing cells that triggered a beneficial response, he said.
The study authors say the exact mechanism is not known but that it might be an “immunomodulatory effect” conferring the benefit.
“People really don’t know,” Berman said. “I don’t think there is a hard and fast explanation. This was pretty intriguing stuff. It was impressive data.”
The trial sponsors will likely go on to a larger study, which Berman says AU plans to participate in, with the hopes of getting approval for clinical use.
For many heart failure patients, the end result is either a heart transplant or an assistive device, and patients would like better options, Ber*man said.
“In speaking with folks that enrolled, they were willing to undergo a minimally invasive procedure even if it had not been proven because they were at that point,” Berman said.
Gray will need to come back and give another bone marrow sample so that the cells can be grown into the therapy, but he is looking forward to it and said it is “already in the works.” His goal all along has been to get back to the active lifestyle he used to lead.
“I love to swim,” Gray said. “I like running; I like jogging. I just like taking a walk, just taking a little easy walk.”
Between the stem cells and getting better control of his heart failure, he said his outlook is improving.
“I have good days and I have bad days,” Gray said. “I thank God for them all.”
By Tom Corwin
Staff Writer
Sunday, April 24, 2016
Ever since he took part in a clinical research study two years ago at Augusta Uni*ver*sity where he either got stem cells or a placebo, Gene Gray has been looking for signs that might clue him in.
Gene Gray took part in a trial that looked at using stem cells to treat heart failure patients. He was given a placebo but now has the chance to receive the treatment.
“I’ve had good things happen to my heart so I thought I might have got them, and I’ve had bad things happen to my heart so I thought I might not have got them,” he said.
It turns out he got the placebo, but he has the opportunity to come back and get the real thing, which he plans to do soon.
The 52-year-old Augustan was one of 109 patients to take part in the largest clinical trial to look at using the cells as a potential treatment for heart failure patients. The study was a double-blind randomized control trial, meaning neither the patients nor the physicians injecting the cells into their hearts know whether it was the therapy or a placebo, a necessary step to avoid bias clouding the results.
“The strength of the study was really that it was randomized and it was double-
blinded,” said Dr. Adam Ber*man, a cardiologist and associate professor of medicine at AU who enrolled five patients including Gray into the trial.
And it showed results. There was a 37 percent reduction in the number of events patients suffered in the cell therapy versus those who got the placebo. This happened despite one of the critical measures studied in heart failure patients, the ability of the heart to send out blood, not improving any better in the therapy group versus the placebo.
“And yet we saw better outcomes with the cell therapy group,” Berman said.
What might be happening is a “paracrine response,” where the cells sent signals to the nearby ailing cells that triggered a beneficial response, he said.
The study authors say the exact mechanism is not known but that it might be an “immunomodulatory effect” conferring the benefit.
“People really don’t know,” Berman said. “I don’t think there is a hard and fast explanation. This was pretty intriguing stuff. It was impressive data.”
The trial sponsors will likely go on to a larger study, which Berman says AU plans to participate in, with the hopes of getting approval for clinical use.
For many heart failure patients, the end result is either a heart transplant or an assistive device, and patients would like better options, Ber*man said.
“In speaking with folks that enrolled, they were willing to undergo a minimally invasive procedure even if it had not been proven because they were at that point,” Berman said.
Gray will need to come back and give another bone marrow sample so that the cells can be grown into the therapy, but he is looking forward to it and said it is “already in the works.” His goal all along has been to get back to the active lifestyle he used to lead.
“I love to swim,” Gray said. “I like running; I like jogging. I just like taking a walk, just taking a little easy walk.”
Between the stem cells and getting better control of his heart failure, he said his outlook is improving.
“I have good days and I have bad days,” Gray said. “I thank God for them all.”