View Full Version : Cardiac Stem Cell Clinical Trials in NC

03-28-2010, 03:45 PM
Hope for Healing

By Richard Craver | Journal Reporter

Published: March 28, 2010

Updated: 03/28/2010 12:25 am

Most local clinical trials tend to be more about improving the quality of life for thousands of annual participants through experimental treatments than saving someone's life.

But sometimes, as with three local residents, they can accomplish both.

For Jim Pepper of Winston-Salem, participating in a congestive heart failure study at Wake Forest University Baptist Medical Center led to the discovery of undetected blockage and a successful triple bypass.

For Jack Yarbrough of Winston-Salem, taking part in a stroke-prevention trial at Forsyth Medical Center involving stents in a carotid artery last May enabled him to withstand a series of mini strokes just four months later.

For Ricky Haynes of North Wilkesboro, participating in a very limited, two-year national study brings hope that severe damage to his heart could be reversed with the use of adult stem cells. He is the first of two local patients that Wake Forest Baptist has found through five months of searching to qualify for the study. The second began the study Friday.

Although the stories of the three men are unusual, they do point out one of the benefits Triad residents have in living near two large medical centers -- the chance to participate in original, groundbreaking research.

Each man says with confidence that their participation is why they are alive. They also hope that their willingness to volunteer will carry benefits well beyond their lives.

"I honestly believe if I had not had the stent work done, I would not have been able to make it through the stroke because I would not have had enough blood flow to my brain otherwise," Yarbrough said.

"We felt that we are all beneficiaries of these kinds of trials, and perhaps this could help future family members as well."

Symbiotic relationships necessary for trials

Clinical trials require, by nature, symbiotic relationships between health-care researchers and local patients to work.

Researchers benefit from lower costs because they don't have to recruit patients from outside the region.

For the medical centers, performing well in high-profile studies can beget additional research in a highly competitive field, attract tens of millions of dollars in grants and raise their national reputation.

For patients, having clinical trials close by can mean access to experimental drug compounds otherwise unavailable, or at the least, the standard treatment for the illness or disease.

Some patients are paid to participate, particularly by research groups that represent a local cottage industry. Those groups typically are not affiliated with the two health-care systems and keep a low profile outside of advertising for patients.

"The hospitals offer some of the best that medical care has to offer, with the studies representing a cutting-edge element," said Bob Romanchuk, the director of the Novant Clinical Research Institute. He said that the institute does about 150 annual studies on between 1,000 and 1,500 patients.

"We've never had an occasion where we've needed to ask for patients for a clinical trial. We typically are referred patients by physicians who are aware of our work.

"The patients are told that there is no guarantee of the procedure working," he said. "But for many of them, the trials hold out hope when they are tapped out on other treatment options."

From heart attack to stem-cell study

Haynes was in perhaps the direst situation of the three men.

He was shoveling snow outside his house on Jan. 30 when he began to feel weak in his chest and have sharp pain in his jaw.

Hoping that it was just a bad case of indigestion -- but worried that it was something worse -- Haynes drove himself and his wife to Hugh Chatham Memorial Hospital in Elkin. Doctors there determined that he was having a major heart attack. They gave him blood-thinning medication and had him transferred to Wake Forest Baptist.

A medicated stent was put into his left artery the next day, but at least 30 percent of his heart had been severely damaged.

As doctors reviewed Haynes' condition, they determined that he was the first local candidate to qualify for the national adult stem-cell study involving Osiris Therapeutics since the doctors began searching in November.

Among the criteria was being available to participate within seven days of a first heart attack; having undergone an angioplasty procedure; being healthy overall, with no history of alcohol or tobacco abuse; having no history of cancer; and a heart function within a limited baseline range.

After extensive prayer and talk with family members, Haynes chose to participate in the study even though he was not guaranteed to receive the stem cells. He was given an infusion on Feb. 4 and recently had a good checkup report on the first of quarterly examinations over the next two years.

"I believe God let me live so I could help with this study," Haynes said. "I was told that most people would have died with my kind of heart attack.

"I was nervous about participating, but then again, this is my only hope at repairing my heart rather than just trying to prevent congestive heart failure from setting in."

Preliminary studies on the adult stem cells hold promise that they can not only repair severe heart damage but also improve heart function.

"Cardiologists today are unable to reverse cardiac deterioration following a severe heart attack," said Dr. Sanjay Gandhi, a cardiologist who is leading the Wake Forest Baptist segment of the study.

"If stem cells can effectively prevent or repair heart-muscle damage, there is potential to meaningfully reduce long-term complications, such as repeat heart attacks and heart failure," Gandhi said.

2,079 volunteers in past two years

Hospitals in Novant Health Inc.'s Triad region have either sponsored or conducted clinical research affecting 2,079 volunteers in 111 studies within the past two years.

By comparison, as an academic research medical center, Wake Forest Baptist has 659 active Phase I-IV clinical trials, of which 119 are initiated by local researchers, according to its clinical-trials office.

For example, in April 2008, the Wake Forest Institute for Regenerative Medicine landed a key role in a five-year, $42.5 million grant from the U.S. Defense Department that focuses on the use of regenerative treatment for lost limbs or severe burns -- the signature injuries of the wars in Iraq and Afghanistan.

Last November, Wake Forest University School of Medicine was named as the coordinating center for a $114 million, nine-year study by the National Institutes of Health.

The goal of the study is to determine whether maintaining blood pressure at levels lower than current recommendations can further reduce the risk of cardiovascular and kidney diseases, or age-related cognitive decline. The medical school will also serve as a clinical center for the Southeast, which includes about 1,000 local participants. In total, the medical school will receive $49.3 million of the project's financing.

Although the competition for studies can be intense, Forsyth and Wake Forest Baptist cooperate on some research, such as a study regarding premature infants and pregnant mothers.

The Comprehensive Cancer Center at Wake Forest Baptist draws thousands of patients a year from a six-state region in part because of its ability to secure National Cancer Institute studies.

"Our ability to discover drugs, devices and software is a key component of why we continue to participate in high-profile studies," said Dr. Frank Torti, a cancer specialist at Wake Forest Baptist who serves as the vice president for strategic programs. He also runs the cancer center and heads the cancer biology department.

"A new drug can play a role in tipping the scale of a disease from incurable to curable on an incremental basis, although at times it can happen much quicker than that," Torti said.

"At the least, a participant who does not get the experimental drug compound is getting the best-known treatment as part of the study," Torti said.

A long family history of strokes

Yarbrough's family has a long history of strokes, with his sister and brother dying as a result. Yarbrough also is a cancer survivor and an asthmatic.

A routine medical check found that Yarbrough was having problems with his carotid arteries -- the main arteries of the neck going to the brain. Yarbrough said that the doctors found the left carotid artery was 95 percent blocked, and that he was at risk for a stroke at any time.

Forsyth medical officials asked him to volunteer for the Carotid Revascularization Endarterectomy vs. Stenting Trial, or CREST, a study being conducted at 117 medical centers in the United States and Canada. There have been at least 43 local participants over the past two years -- the most of any of the centers.

The stent is new and a less invasive way to widen the blocked area in the carotid artery and capture any dislodged plaque than the standard surgery. Both the stent and surgery carry significant risks, but the recovery time for the stent typically is two to three days compared with two to three weeks for the surgery.

"It was a little scary to have my life put into a computer for selection, but we decided to trust God and go with the study because we felt the odds were good," Yarbrough said.

Less than four months later, Yarbrough required hospitalization for the series of mini strokes related to his right carotid artery. He went through a similar procedure to clean out that artery and has been fine ever since, he said.

"This study and my doctors gave me a new lease on life," Yarbrough said.

Dr. Donald Heck, a neurointerventional radiologist at Forsyth, said that many of the participants in the CREST study took an altruistic approach, even though they were not getting paid. "While they are benefiting from the study, they have high hopes of others benefiting as well," Heck said. "How regular the procedure will be used will depend on how Medicare views the data from the trial because private insurers tend to look at what it will cover to determine what they cover."

What the study has found is that the age of the patient made a difference. For those 69 and younger, the stent performed slightly better, and for those ages 70 and older, the surgery performed slightly better.

"The key to the study is that we have determined we have two safe and effective ways to treat a blocked carotid artery," Heck said.

Understanding heart disease better

Pepper said he has a better -- and too-close-for-comfort -- understanding of why heart disease is considered as a "silent killer."

He volunteered to participate in the Predict study at Wake Forest Baptist in February 2009 after being encouraged by his wife, Linda, after her own experience with a study measuring the effect of diet and exercise on osteoarthritis of the knee.

The Predict study is trying to determine what the risks of congestive heart failure are among people ages 55 to 85 that have high blood pressure and/or diabetes and/or coronary artery disease. It measures the pumping function and blood vessels of the heart.

"I wasn't having any symptoms, but they found excessive blockage in two main arteries during a heart catheterization," Pepper said. "The next thing I knew, I was in the operating room having a triple bypass."

Since the surgery, Pepper has had 36 rehabilitation sessions at the medical center. He also has dropped 30 pounds by changing his diet and has gotten his cholesterol under better control. "It's a real blessing that Linda talked me into the study," Pepper said. "I wasn't compensated for the study, but saving my life is reward enough."