Injections of autologous BMC directly into the endomyocardium of no-option patients with severe coronary artery disease improves left ventricular ejection fraction and exercise tolerance.

by Martha Kerr

Injections of autologous bone marrow cells (BMC) directly into the endomyocardium of no-option patients with severe coronary artery disease (CAD) improves left ventricular ejection fraction and exercise tolerance, results of the international PROTECT-CAD trial show.

The findings are published in the December issue of the European Heart Journal.

"Our study is the first randomized controlled clinical trial on the use of bone marrow stem cells to treat patients with chronic severe coronary artery disease without other options," lead investigator Dr. Hung-Fat Tse of the University of Hong Kong Dr. Tse told Reuters Health.

In the trial, involving 28 patients with severe CAD, bone marrow cells were harvested and patients were randomized to low-dose or high-dose autologous BMC injections directly into the endomyocardium, or to a control procedure consisting of injection of autologous plasma.

"In our study, direct intramyocardial injection of bone marrow cells is performed with a catheter-based procedure without the need for open heart surgery," Dr. Tse explained. "Furthermore, the approach (allows) the delivery of stem cells directly into the heart muscle, even in patients with complete occlusion of their arteries."

Patients received a mean of 14.6 injections targeted under single-photon emission computed tomography (SPECT) and magnetic resonance imaging (MRI) guidance to ischemic areas of the myocardium.

Baseline exercise treadmill time was 439 seconds in controls and 393 in study subjects. At six months, treadmill time had deteriorated to 383 seconds in controls but improved to 464 seconds in BMC-treated patients.

Compared to control injections, BMC injections resulted in a significant increase in LVEF and a decrease in New York Heart Association (NYHA) class at six months, but Canadian Cardiovascular Society (CCS) class was reduced similarly in both groups.

There were no acute or long-term complications, including ventricular arrhythmias, myocardial damage or development of intramyocardial tumor or calcification associated with BMC implantation.

"Our results demonstrate that this treatment is a safe and feasible therapy in patients with end-stage coronary artery disease to improve their symptoms and functional capacity," Dr. Tse commented. "In this study, most of the patients still had a relatively normal or mildly impaired heart failure. In the next study that we have planned, patients with poorer heart function will be recruited to test whether this therapy can improve heart failure in those patients."


Source: Reuters

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