Posted on October 17, 2002 at 9:18 a.m.
BIRMINGHAM, AL — UAB cardiologists are participating in a nationwide gene therapy trial to determine whether experimental gene therapy can stimulate the growth of new blood vessels in the heart — a process known as angiogenesis. Successful angiogenesis could benefit patients like Jack Thomason, Jr., who has been plagued with symptoms of heart disease like angina for more than 15 years.
The study will examine whether angiogenesis can relieve angina in patients who have not been helped with other standard therapies such as medications, angioplasty or surgery. Angina, the medical term used to describe discomfort in or around the chest, is caused by the narrowing of the blood vessels that supply blood to the heart.
On August 29, Thomason received either a dose of the gene-therapy study drug or a placebo during an hour-long catheter procedure performed by Greg Chapman, M.D., director of UAB interventional cardiology and an investigator in UAB’s part of the trial. UAB is one of more than 100 sites participating in the trial, sponsored by Berlex Laboratories, Inc.
In the catheter lab, Chapman threaded a tiny needle through a tube inserted in Thomason’s groin that snaked through his arteries until it reached his heart and the major sites of coronary blockage. Chapman then delivered the dosage directly to the sites of blockage. Neither Thomason nor Chapman will know whether he received gene therapy or a placebo for at least a year — when researchers are allowed to break the double-blind seal.
Thomason has suffered with ischemic heart disease and long bouts of painful and debilitating angina since his first coronary heart attack in 1985. He describes an episode as a tightness and squeezing pain in his chest that often hurts so bad he has to sit down. “I can’t take the garbage out without having to sit down and take a rest.
“It feels exactly like the early stages of a heart attack,” he said, “which is scary because I know what a heart attack feels like. So every time I have pain I have to wonder if this is just angina or an actual heart attack. You feel like you are on the brink all the time.”
The trial uses a modified adenovirus, similar to the one that sometimes causes the common cold. The virus is unable to cause disease, but is used as a delivery system to introduce genetic material into the body. In this case, the adenovirus is then combined with a specific gene that has been found to stimulate the growth of new blood vessels.
Patients are randomly assigned to receive a high dose, low dose or placebo. Each patient has a 66 percent chance of receiving the gene therapy.
As part of the study, Thomason had to record his angina for 22 days before being admitted to the hospital. Of those 22 days, he said there were only four when he experienced no pain, but he averaged pain three to five times and sometimes suffered seven or eight times a day.
“This is a very debilitating disease. You can’t work, you can’t cut your grass, you can’t play with your grandchildren, you can’t run errands with your wife at the mall. And if my participation in this study helps even one person get some relief, then it was worth it, even if I got the placebo.”