Cell therapy could slow decline in heart failure patients …

But that means about 2.5 million Americans live with heart failure that blocks blood vessels and reduces blood supply to the body.

A new study provides an early indication that cell therapy using cells from bone marrow could one day help treat heart failure.

Researchers gave 60 patients with heart failure an injection of the therapy in the heart and compared their rates of death and heart problems to those of 66 similar patients who received a placebo injection of saltwater in the heart.

The researchers found that, during the year following the treatment, the patients who received the cell therapy had a 37% lower rate of death and hospitalization for heart failure-related problems, such as fluid buildup in the body or shortness of breath, compared with the placebo group. In the cell therapy group, 3.4% of the patients died and 51.7% were hospitalized for heart problems, whereas 13.7% of the placebo group died and 82.4% were hospitalized.

In the year after the injection, 20.3% of the patients in the cell therapy group experienced an adverse event such as infection or stroke, compared with 41.8% of the placebo group. "It was surprising that the (placebo) patients did significantly worse," Patel said. This could have been because they underwent the same invasive procedures as the treatment group, but did not receive the same potentially beneficial cell therapy, which could have anti-inflammatory effects that decreased adverse events, he said.

Nevertheless, this therapy will need to be tested on more patients, Povsic said. "Although the study in The Lancet is very encouraging, it's still a relatively small study by cardiovascular standards. In heart disease we typically study hundreds to thousands of patients," he said.

The researchers and Vericel are hoping to start a larger phase 3 clinical trial of Ixmyelocel-T that includes more heart failure patients. The new study was a phase 2 trial, and these trials generally focus on establishing the effectiveness and safety of a new therapy.

Earlier cell therapies used all the cells in the bone marrow instead of selecting for certain types of cells, and thus might have been diluting their beneficial effects, Povsic said. "We are moving more and more away from first generation cell therapy," said Povsic, who is involved in two ongoing trials looking at the effect of selected cells from bone marrow in patients with heart failure or angina, a type of heart disease that reduces blood supply to the heart.

No cell therapies have been approved worldwide for heart failure patients. There are also no approved cell therapies for other types of heart disease in the United States, but several therapies are available in Asia, including a stem cell-based treatment for people who have had a heart attack.

The therapy in the new study would be appropriate for patients who have heart failure and are getting worse, despite taking medicines such as beta blockers and ACE inhibitors, Patel said. Nearly all the patients in the study were on one of these drugs. However, the therapy would not be appropriate for patients whose heart failure is so bad that they are often hospitalized for heart complications, Patel said. These patients would be candidates for a heart transplant or left ventricular assist device.

"There's a growing population of (heart failure) patients that are on medicines and who continue to have significant symptoms," Povsic said.

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Cell therapy could slow decline in heart failure patients ...