Chicago Council on Science and Technology

Courtesy: Medill Reports Chicago

Doctors at Northwestern Memorial Hospital have successfully treated symptoms of heart disease with their patients’ own stem cells as part of a phase-two trial.

The hospital’s Feinberg Cardiovascular Research Institute is one of 26 sites across the country participating in the study. The final phase-three trial could begin at the end of this year or early next year, as more sites and patients come onboard.

Heart disease is the leading cause of death in the United States. An American has a coronary attack every 25 seconds, and every minute someone dies from heart disease, according to the Centers for Disease Control and Prevention.

Dr. Douglas Losordo, a cardiologist who heads the research institute, said the phase-two success insures that phase-three is right around the corner. “The phase-two study, from the first patient in till the last patient out, took about two years,” Losordo said. “We expect phase-three to be about the same but with more patients at more research sites.”

Using technology developed by Baxter International Inc., researchers at the 26 sites were able to take stem cells from the patients’ bone marrow and inject them directly into the heart muscle to regenerate the damaged areas and increase the supply of oxygen back to the heart. Losordo said the results showed promise in almost every patient.

“We as adults have cells in our body that can be used to regenerate different tissues,” he said. “Simply by putting these cells in an area that lacks blood supply, they send signals to other cells to start forming new blood vessels.”

Some 167 adults participated in the phase-two study at the research sites throughout the country. The patients suffered from severe angina, or chest pain, nausea, fatigue and shortness of breath caused by a lack of oxygen to the heart. In cases of severe angina, traditional medical treatments such as angioplasty or bypass surgery are not always an option.

According to Losordo, research in the phase-two trial showed that patients experienced less pain and were able to engage in more physical activity than before the treatment. Within several months, patients showed signs of improvement and their angina symptoms became less severe.

In most angina cases, the lack of blood supply is due to a narrowing of the coronary arteries that place people at greater risk of heart attack. Angina can make it difficult for patients to stay active, as the pain can be consistent and debilitating. Those suffering from severe cases experienced chest pain from normal activities such as brushing their teeth or even just resting.

Patients were given a drug called GCSF, which stimulates the release of the purified stem cells, known as CD34+ cells. Using Baxter’s ISOLEX 300i Magnetic Cell Selection System, doctors extracted the CD34+ stem cells from the patient’s own bone marrow.

The cells are then injected into 10 locations of the patient’s heart muscle, to create new blood vessels, a procedure that is fairly non-invasive. The FDA approved the ISOLEX 300i Magnetic Cell Selection System in 1999 mainly for use in cancer research.

“My lab identified CD34+ cells as potentially therapeutically useful for heart disease and other types of diseases,” Losordo said. “So we contacted Baxter because they have this device that was capable of selecting the cells we needed for this type of procedure.”

“Dr. Losordo approached Baxter with the idea and Baxter sponsored the study
in order to continue advancing the science of adult stem cell therapies for
cardiovascular disease,” said Baxter spokeswoman Laura Grossmann Jacobs.

Baxter is providing funding for the trials at all 26 sites.

Jacobs said the data so far is encouraging, but additional studies are necessary to establish this as a potential treatment. “More evaluation of the data is needed before we determine the next steps of the trial,” she said.

Losordo said therapies could be available in the next several years, but it is hard to predict when exactly that could happen. “It all depends on when phase-three can be completed and how long it will take the [Food and Drug Administration] to approve the treatment,” he said. He estimates that the treatment could be available within the next four years, both for heart patients, and for other types of diseases.

“People with severe blockages in the leg arteries can have severe symptoms of pain and ultimately tissue loss like ulcers or gangrene,” he said. “So we completed a small 28 patient pilot of that which actually suggested a reduction in amputation rate in patients who received the cells.”

This study could be the first in a series that can help treat various diseases. “Results from the study add to the growing body of knowledge for the therapeutic potential of adult stem cell therapies,” Jacobs said.

- Tina Amirkiai