Intracoronary Bone Marrow Transplant Shows Benefit Post-MI

Peggy Peck

November 12, 2003

Nov. 12, 2003 (Orlando) -- Results of the first randomized controlled trial of intracoronary autologous bone marrow cell transfer after myocardial infarction (MI) suggest that the experimental procedure can regenerate the heart and improve ventricular function, according to senior investigator Helmut Drexler, MD, professor of medicine at Hannover Medical School in Germany.

Dr. Drexler presented the results of the late-breaking clinical trial here at the American Heart Association Scientific Sessions.

Patients who underwent percutaneous coronary intervention (PCI) plus bone marrow cell transfer increased left ventricular ejection fraction (LVEF) by 6.7% at five to six months after MI while patients who underwent PCI alone increased LVEF by just 0.7% ( P < .01).

Sixty patients with acute ST-elevation MI were enrolled and randomized to either the bone marrow cell transfer group or to a control group. All patients underwent successful rescue or primary PCI using stents, Dr. Drexler said. Patients with hypokinesia or akinesia of two thirds or more of the left ventricle anterior, septal, lateral, or inferior wall as determined by angiography immediately after PCI were eligible for the study.

Dr. Drexler told Medscape that the transfer was "even more beneficial among patients who had a late rather than early reperfusion, but this subset of patients is so small that it is too early to determine if this is a real effect or merely a chance observation."

Bone marrow cells were harvested from the hip four days after MI. "Harvesting was done under conscious sedation and was well tolerated by patients," Dr. Drexler said. The nucleated bone marrow cells were enriched by 4% gelatin-polysuccinate sedimentation and were transplanted into the infarct artery, distal to the lesion, through the central lumen of an over-the-wire balloon catheter. The cells were harvested in the morning and transplanted that same evening, he said.

LVEF was assessed by magnetic resonance imaging (MRI) after PCI but prior to cell transfer. Five to six months later, LVEF was again assessed by MRI, he said.

Patients were monitored by repeated Holter and electrophysiological studies and "there was no evidence of pro-arrhythmic effects in the bone marrow transplant group," Dr. Drexler said.

Mayo Clinic cardiologist Raymond J. Gibbons, MD, said that several groups are involved in small clinical studies of cell transfer, but "it appears that the Germany is in the lead" with respect to this new technology. Asked about this lead, Dr. Drexler speculated that Germany has moved more quickly because "we can get this type of research approved more rapidly. A U.S. researcher told me it would take two years for him to get this by an institutional review board. We put this study together in about five months."

Robert Bonow, MD, chief of the division of cardiology at Northwestern University in Chicago, Illinois, told Medscape that the cell transfer technology is still preliminary and experimental, but that "these early results are very promising." Moreover, he said the cost of cell transfer could be "pretty cheap. The harvesting isn't difficult since most centers are set up to harvest bone marrow and since they aren't expanding the cells, I think it could be done pretty easily."

Dr. Drexler estimated that cell transfer would add about $1,500 to the cost of standard PCI.

AHA Scientific Sessions 2003: Late-Breaking Clinical Trials. Presented Nov. 10, 2003.

Reviewed by Gary D. Vogin, MD

 

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