Heart Treatment Yet Another Moral Stem-Cell Option

Clinical trials at the Texas Heart Institute have shown promise for extremely effective heart tissue repair. It’s another example of progress being made with morally-unobjectionable adult stem cells.

HOUSTON — In July of 2006, caterer Carron Morrow of Montgomery, Ala., was hanging Japanese lanterns for a wedding when she was overcome by a faint feeling. What she thought was heat stroke turned out to be a heart attack — the fourth she had suffered since the age of 39.

The fraction of blood pumped out of the ventricle with each heart beat — her “ejection fraction” — had plummeted from 45% to 25%. The right side of her heart had basically closed up. A stent was not an option for her, and she began to consider adding her name to the list of thousands seeking a donor heart for transplant.

As a mother and grandmother with a flourishing business, the 58-year-old Morrow struggled with denial and depression. “Death was just not in the plan,” she said in a phone interview.

Her mother got to work researching options for her daughter, and learned about the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston.

Dr. Emerson Perin, who heads the institute’s new stem-cell center, and Dr. James Willerson, president of the University of Texas Health Science Center at Houston, were accepting patients for a clinical trial to treat end-stage heart failure using the patients’ own bone-marrow stem cells. Because of the experimental nature of the treatment, only patients with no other options could be accepted.

“I was at the end of my rope — there was no hope,” Morrow recalled. Understanding the risks, she considered that the research would still help someone even if she died.

When she flew to Houston in October, Morrow was unable to walk or speak easily.

“I was in a wheelchair, and I couldn’t say two words without gasping for air,” she said. “I couldn’t walk more than 20 steps.”

She was selected to be part of the trial, but did not know whether she was one of the 20 patients who would receive adult stem-cell treatment or one of the 10 control patients who would receive placebos.

The actual procedure was straightforward. Early on the morning of Nov. 1, 2006, bone marrow was drawn from her hip. The stem cells were extracted, and four hours later Perin inserted them via catheter directly into Morrow’s heart. She left the hospital by 7 p.m., and went out to dinner with her mother.

Although she was not to know officially until April whether she had received the adult stem-cell treatment or the placebo, she felt stronger. In December, six weeks after the treatment, Morrow catered a seated meal for 650 people.

“I wasn’t in a wheelchair any more,” she said. “I wasn’t gasping for air.”


‘No One Had to Die’

Six months later, her ejection fraction was up to 45%, and she was able to work an 80-hour week. She returned to her workout at a nearby fitness facility.

“This is a win-win situation,” Morrow said. “No one had to die to donate a heart. The insurance companies didn’t have to pay thousands of dollars to make a foreign object compatible with my body.”

Morrow’s story is yet one more success story in the ongoing area of stem-cell research and adds to the long list of treatments that have been used with adult stem cells. Yet, many in science and politics continue to push funding for embryonic stem-cell research.

Even though a citizens’ initiative in Florida failed to qualify for the November ballot, lawmakers in Tallahassee said they will introduce legislation that would require the state to spend $20 million a year for 10 years on grants to researchers doing studies using stem cells, including those using embryonic stem cells, the Associated Press reported Jan. 15.

In Houston, Perin and Willerson pursued FDA approval for the trial after a ground-breaking pilot study they did in Brazil in 2000. Perin was inspired by those first amazing results.

“These people in Brazil were reborn,” he said. “The stem-cell injections ‘woke up’ their hearts.”

One patient from that trial went from planning his funeral to dancing at Brazil’s annual Carnaval. In a telephone interview, Willerson said that the American study is a duplicate of Brazil except that the experimental setup is more rigorous.

“This is a randomized, blinded study,” he said. But as in Brazil, “the patients all had severe coronary heart disease. They were desperate.”

According to Willerson, the Brazil study, which ran from 2000 to 2002 was “the first in the world to treat heart failure with bone-marrow-derived stem cells.” A German study that made the news in 2001 used bone-marrow stem cells to treat heart attack victims.

Since that announcement, labs all over the world have started exploring the phenomenon, but more attention has gone to the acute condition — heart attack — rather than the chronic one — heart failure and coronary disease. The Heart Institute is investigating both.

The Houston research center also stands out for its use of a guided catheter for direct delivery of the stem cells to sites near the affected area. Other labs are experimenting with intracoronary injection or surgical incision.

“We like to use the direct injection,” Willerson explained. “The catheter allows one to … identify where the cells are needed. When the cells are put into the arteries [via intracoronary injection], many of them leave the heart or can actually obstruct the arteries.”

The underlying question of all this research is: What do adult stem cells do to repair the heart?

A follow-up examination from the Brazil work shows that the hearts of treated patients have more blood vessels, suggesting that the stem cells either transform into new blood vessels or stimulate angiogenesis, and so improve blood flow and oxygen delivery. It also appears that the bone-marrow stem cells have a “paracrine effect,” that is, they recruit healing proteins and chemicals to the damaged site. Other possibilities are also being tested.

While the Heart Institute has completed this trial on patients with end-stage heart failure, it is still recruiting candidates for three other studies. One that is most unusual even in a cutting-edge field is an investigation using stem cells taken from the patients’ own fat.

In September 2006, the New England Journal of Medicine published the results of three large trials in Europe that tested intracoronary delivery of bone-marrow stem cells to heart attack victims. Two of the studies showed modest but significant improvement, the third showed no improvement.

Evaluating these results, editor Anthony Rosenzweig offered cautious optimism: “We should guard against both a premature declaration of victory and a premature abandonment of a promising therapeutic technique.”

In a recent e-mail exchange, Rosenzweig said this continues to be his assessment. There is not yet enough data for an independent evaluation of the catheter-delivery method used by THI.

“We were doing very different things [from the European labs] except using the same cells,” said Willerson. “They were treating acute heart attacks; we were doing studies for treatments in heart failure.”

The European labs were also using intracoronary delivery, not the direct injection. “We’ve done experiments in animal models and we believe injection with the NOGA catheter is superior,” Willerson added.

In addition to side-stepping the moral quandary, bone-marrow stem cells have the advantage of immuno-compatibility since they are taken from the patient’s own body. The evidence is mounting that they are not only safe but effective.

For people like Carron Morrow, that’s sufficient argument.


Wendy-Marie Teichert is based in San Luis Obispo, California.