NEW YORK (Reuters Health) – Intramuscular implantation of autologous bone marrow mononuclear cells is associated with long-term improvements in limb ischemia and may prevent or at least delay the need for amputation, according to a report in the American Heart Journal for November.

In an earlier study, Dr. Satoaki Matoba, from Kyoto Prefectural University of Medicine, Japan, and co-researchers showed the feasibility of this angiogenic cell therapy. Now the team has assessed 3-year safety and clinical outcomes, looking at mortality and the leg amputation-free interval.

A total of 74 patients with peripheral artery disease (PAD) and 41 with thromboangiitis obliterans (TAO) were included in the analysis. The median follow-up period for surviving patients was 25.3 months.

The 3-year survival rates for PAD and TAO patients were 80% and 100%, respectively. The corresponding amputation-free rates were 60% and 91%. Multivariate analysis showed that severe rest pain and repeated bypass surgery were both predictive of a shorter amputation-free interval.

No significant changes in ankle brachial index or transcutaneous oxygen pressure were noted, although improvements in leg pain, ulcer size, and pain-free walking distance were still apparent at least 2 years after treatment.

“These findings suggest that the angiogenic cell therapy using intramuscular implantation of bone marrow mononuclear cells is safer and not inferior to the conventional revascularization therapies in patients with PAD whose complications of coronary artery disease and cerebrovascular disease were preinvestigated and pretreated,” the authors conclude. The risk/benefit profile is even greater in patients with TAO, they add.

Reference:
Am Heart J 2008;156:1010-1018.