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Doctors at the University of Utah treated actor and celebrity dad Ernie Lively's failing heart this month with stem-cell therapy as part of a clinical trial testing a new, minimally invasive procedure and drug.
Lively moved to Heber City to ski after retiring, but his health declined in the wake of a 2003 heart attack until he couldn't walk 45 steps at home without a rest.
"I live here because of the outdoor life, and I couldn't enjoy it," the 66-year-old Lively said in a statement provided by the U. "I didn't have enough energy to do much of anything."
He became a patient of Amit Patel, U. director of clinical regenerative medicine and tissue engineering, in February after Patel and his team performed emergency surgery when a complication from an angiogram left the actor with a severed aorta and coronary artery problems.
Lively was also interested in stem-cell therapy and, on Nov. 7, he became the first person treated with an experimental retrograde gene therapy technique Patel and his team developed. It "infuses" a gene therapy drug into the entire heart rather than injecting stem cells directly into the tissue.
The drug Patel is testing contains high doses of genetically engineered human DNA that acts as a "homing signal," calling the body's own stem cells to repair the heart. Developed by Cleveland-based Juventas Therapeutics, it's delivered by a catheter placed through a vein in the groin and into the back of the heart. An inflated balloon, meanwhile, blocks the blood flow so the medicine isn't immediately pumped out of the heart again.
"Basically, it would be like when you're basting the turkey ... in this case you're marinating the heart," Patel said. The patient they've now performed the method on four so far is awake the whole time and typically leaves the hospital the next morning.
Stem-cell therapy for heart disease has been researched for a decade now, using several techniques, but no therapy has yet worked well enough to treat patients regularly, said Jeffrey Anderson, the director of cardiovascular research at Intermountain Medical Center in Murray.
"We've found stem-cell work is much more complex than we thought," he said. The concept of signaling the body's stem cells has been tried before.
"The history of those has been mixed or negative," Anderson said. "None have made it to be used or proven clinically."
But Patel's "cutting edge" new work shows promise, he said.
"It's very exciting that they're doing this ... it's early research, so we'll just have to see," Anderson said. "It's something new, so there's always the chance this might be the way to go."
Patel and his team are teaching it to other doctors around the country as part of the clinical trial of 72 patients during the next few months. If approved by the Food and Drug Administration, the technique and drug would be available to the general public in about three years. The costs and insurance coverage on the procedure won't be known until about a year later.
The method could open up stem-cell therapy to more patients such as Lively whose hearts are already weakened by coronary disease, Patel said.
"These are patients who we normally couldn't help," he said. " ... The only option would be a partial artificial heart or a heart transplant."
The retired actor is now at home recovering.
"I woke up this morning and told my wife, 'I haven't felt this good in years,' " Lively said in a statement provided by the U. That experience is a bit faster than doctors typically expect results usually it takes one to four months, Patel said. The results also aren't permanent.
"Nothing we do is a cure. They still have to take medications," Patel said, but with the new retrograde gene-therapy procedure, "re-dosing, I think, is realistic."
Meanwhile, Lively plans to spend more time with his six grandchildren split between Utah and California and hopes for more. He said his youngest daughter, former "Gossip Girl" star Blake Lively, anticipates starting a family with actor-husband Ryan Reynolds.
"She says she wants 30 kids," he said. "I said, 'Why don't you start with one?' "