Las Vegan in stem cell study

LESS THAN 30 DAYS AFTER TREATMENT

A shot in the arm doesn't sound like much of a birthday present. But Anthony Salas couldn't have been happier as the needle sank deep into his left bicep.

Maybe, just maybe, this would be the beginning of the end of the heart-related chest pain that often has him eating nitrogylcerin tablets or sipping morphine.

The injection that left the Las Vegan smiling on his 58th birthday was of G-CSF, a drug used to move cells from the bone marrow into the bloodstream. If all went as planned, after four more days of these shots, doctors would be able to collect enough special stem cells from Salas' own blood to then help him help himself.

Stem cells, the basic building blocks of the human body, are those that have the potential to develop into different types of cells. Researchers believe stem cells can be spurred into developing into most of the 220 types of cells found in the human body, offering the greatest potential for medicine since antibiotics. More than 100 million Americans, scientists estimate, suffer from conditions that may be treated more effectively, or even cured, with stem cells.

On July 30, Salas became part of an experiment known as "Injection of Autologous CD34-Positive Cells for Neovascularization and Symptom Relief in Patients with Myocardial Ischemia." That is better known, by patients and doctors alike, simply as "stem cell therapy."

The study, led by doctors Douglas Losordo in Boston and Richard Schatz at Scripps Green Hospital in La Jolla, Calif., is investigating whether a dose of a person's own stem cells can help the heart grow new blood vessels, which would mean more blood and oxygen would get carried to the heart muscle.

Because the recurrent pain known as angina is caused by too little blood getting to the heart muscle, researchers -- who have seen cell therapy benefit animals -- theorize chest pain will be relieved through the growth of new blood vessels.

"When I found out about this study going on ... it was like a dream come true," said Salas, who has been hospitalized 33 times in the past five years for heart problems.

To Salas, the experiment only has one downside. It's a blind study involving 24 patients on the East and West coasts, so he may be receiving a placebo in the form of salt water.

Three out of four patients in the study will actually receive the stem cells. Even Schatz is unaware of whether he injected the placebo or stem cells into Salas' heart.

"The good part, though, is that if I have been given the placebo, I will still be able to get my stem cells when the study is over in a year," said Salas, who can no longer work as a mechanical designer.

Salas isn't irritated about possibly receiving a placebo, but he is bothered by the political climate and public perceptions regarding stem cell therapy.

"I keep hearing all the time that President Bush outlawed stem cell therapy, and that just isn't true," Salas said. "When I tell people that I'm living proof that stem cell therapy is going on, they say to me, `I thought that was against the law.' "

Bush's Democratic challenger, Massachusetts Sen. John Kerry, has seized upon the issue in the presidential campaign, saying Bush "enacted a far-reaching ban on stem cell research." A recent Zogby International poll found if Kerry were to announce a major initiative in stem cell research to cure diseases, including Alzheimer's, he would gain 11 percent of Bush's voters.

In 2001, Bush limited federal funding of embryonic stem-cell research, citing ethical grounds. Privately funded scientists, however, continue embryonic stem cell research.

Adult stem cell research, like that involving Salas, is supported by both private and public funds. In 2003, more than $200 million of federal money supported adult stem cell research, which carries none of the ethical baggage of studies with embryos, and has had far more success.

In order to collect stem cells from embryos, which typically are left over from fertility clinics, the embryo must be destroyed. Bush, and the many conservative religious groups that support him, note that an embryo represents one of the earliest stages of human life and must be protected, even if it means not saving the life of another.

But researchers believe embryonic stem cells have greater potential than adult stem cells because they may develop into any type of cell in the human body. Adult stem cells, they say, may be less versatile.

Still, the utility of embryonic stem cells, unlike adult stem cells, remains entirely theoretical and they've yet to be used in a single therapy. Particularly unsettling to researchers is the creation of tumors when trying to unleash the power of embryonic stem cells in animals.

"It is true that adult stem cell research is further along," Schatz said. "But like most doctors and researchers, I want to investigate what shows promise for the saving of lives."

In an Aug. 9, 2001, speech regarding stem cell research, Bush said he would allow federal money to be spent only on studying the approximately 60 existing embryonic stem cell lines already created in privately funded laboratories.

Bush said the reason he allowed funding of these lines was because the embryos were already destroyed and the lines had already been created.

Both Salas and Schatz are concerned that few Americans understand that adult stem cell research is already paying big dividends. If people don't realize the success of the current research, they worry that funding won't be increased.

For more than 30 years, bone marrow stem cells have been used to treat cancer patients with conditions such as leukemia and lymphoma. A recent hearing of the U.S. Senate Committee on Science, Technology and Space that was devoted to breakthroughs in stem cell research heard evidence that adult stem cells were showing efficacy for treatment of diabetes, heart disease, sickle cell anemia, acute myeloid leukemia, multiple sclerosis, and non-Hodgkin's lymphoma. Adult stem cells therapy also looks promising for Parkinson's disease.

A huge challenge to making stem cell therapies more commonplace is in identifying and isolating specific cells and then transforming them into a variety of cell types so they can regenerate, heal or work in concert with the body's other cells. Researchers are also dealing with issues of tissue rejection. Ongoing adult stem cell research related to heart disease is especially promising. In addition to the study Salas is part of, another far reaching study is under way at the Houston-based Texas Heart Institute at St. Luke's Episcopal Hospital.

Researchers there have found that by injecting stem cells into the areas of the heart that have sustained mechanical and electrical damage, they have been able to increase blood flow to the heart muscles and have seen improvement in heart conditions.

Within six months of receiving stem cell therapy, one patient there, who couldn't get out of bed because of heart failure, was walking three miles every day, swimming laps, and working eight hours a day at a job he quit because of his health, the researchers reported.

When Salas and his wife, Mildred, hear such stories, they become more optimistic. Salas is very ill. He can't walk 50 yards without angina-related pain radiating in his wrists, arms, chest and jaw. "It's like it clamps me down," he said.

He's had triple bypass surgery. He's also had, in several trips to hospital operating rooms, 33 stents implanted. Stents are small, metallic, meshlike tubes designed to support plaque-damaged arterial walls after a blockage has been removed, usually through balloon angioplasty, a procedure in which a surgeon inserts into a vessel a tiny inflatable balloon.

Though as many as 25 percent of patients who received a stent experience a renarrowing of the stented area, few have the problems of Salas. Almost all of his arterial walls close down within a month of receiving a stent. His oxygen tank follows him wherever he goes, including to the many government and civic meetings he attends to keep busy.

Mildred Salas, whose health insurance covers her husband, hopes if he grows new blood vessels, as researchers believe will happen, his body won't turn on him again. She is afraid that whatever has made his vessels close down will come back again.

Salas' doctor can't say what stem cell therapy will ultimately hold for his patient, but notes traditional treatment has gone as far as possible.