Gene Gray sees his neighbors out running and walking and wishes he could join them, but his heart won’t let him.
“I loved running and I can’t do it anymore,” said Gray, 50. “Long walks, I can’t do that anymore.”
A heart attack three years ago led to a kind of heart failure known as dilated cardiomyopathy, where the heart has become enlarged and weaker and is pumping less blood per heartbeat.
Some of Gray’s own cells, however, might change that.
He is part of a clinical trial at Georgia Regents Medical Center to test whether dosing the heart with specially manipulated stem cells can help heal the damage and improve function. Gray donated a small amount of bone marrow a couple of weeks ago and it was sent off to the lab of the trial’s sponsor, Aastrom Biosciences of Ann Arbor, Mich.
There the company uses a special process to greatly expand some of the cell types in Gray’s sample more than 200 times and greatly reduce others, creating a therapy it calls ixmyelocel-T. Because the clinical trial is double-blinded, Gray will either receive his own cells back or a placebo. But because patients like Gray have no other viable option of rejuvenating the heart muscle, they are willing to take that chance, said Dr. Adam Berman, the director of cardiac arrhythmia ablation services at Georgia Regents. And the company has agreed, if the clinical trial shows some benefit, to let the placebo patients be treated, he said.
“I think that’s very appealing,” Berman said.
In the electrophysiology lab at Georgia Regents on Wednesday, the doctor carefully guided a catheter equipped with a tiny needle around the inside of the left ventricle of Gray’s heart, mapping it while a vivid color display showed the relative health of the different tissues.
A big mass on the left side of the heart glowed red, and “red is dead,” said nurse Frank Cunningham, who assisted Berman from a control room in front of a series of monitors. Healthy tissue is purple and there is a band of blue to light green in between, the area Berman was shooting for, which is “sick but not dead,” Berman said.
The hope is that injected cells can help stimulate that tissue to become healthy again.
Stem cell therapies for heart disease have been tried for years without much success. The old thinking was that the cells would go to the site of damage and become healthy new cells, but that did not appear to happen, Berman said.
“But in terms of stimulating the heart, can we kind of encourage the diseased heart muscle to begin a process that can help it repair?” Berman said. “That’s the more contemporary thinking.”
By manipulating the cell types that were added back, there actually appears to be a reduction in damaging oxidative stress and inflammation, according to an abstract Aastrom put together.
The cell types promoted have been associated with tissue remodeling and new blood vessel growth and an early phase study showed results of improved function and potential “reverse remodeling” of the left ventricle chamber, according to the company.
That would mean “shrinkage of its dimensions from a more dilated, boggy structure to a smaller more normal-sized structure,” Berman said. As he carefully moved around the band of tissue inside the chamber, which was constantly beating and making it essential to find a place where he can hold the tip stable for a minute to pull off the injection, Berman carefully placed 13 injections in the narrow window of tissue on the inside of the left ventricle.
While a common way to measure whether there is improvement in heart failure is to look at what percentage of blood is sent out with each heartbeat, the clinical trial will look at patients like Gray and how they actually fare, Berman said.
“Does it help people live longer?” he said. “Does it keep them out of the hospital? Does it help them feel better?”
Gray will be followed for a year and measured on things such as how far he can walk in six minutes. That was not a fun test initially, Gray said.
“It was a very long six minutes,” he said, laughing.
But if he got his cells back, he is looking for a boost. Even if it was placebo, he is hopeful the trial will show improvement and he will be in line to receive the treatment himself.
“I miss getting out there running and walking,” Gray said.