Application of autologous bone marrow mononuclear cells in six patients with advanced chronic critical limb ischemia as a result of diabetes: our experience.

BACKGROUND AIMS: Previous clinical studies have reported that the injection of bone marrow (BM)-derived mononuclear cells (MNC) results in improvement in symptoms and healing of ulcers in patients with critical limb ischemia (CLI) up to stage IV of Fontaine's classification. However, most patients with Fontaine stage IV CLI limbs had to undergo amputation even after stem cell therapy. We report on six patients, who had poorly controlled diabetes with extensive ulceration and gangrene of limbs because of Fontaine stage IV CLI and had been advised amputation elsewhere, who underwent injection of autologous BM MNC. METHODS: In all six patients, BM was aspirated and the isolated MNC from the BM were injected intralesionally at various sites of the ulcer and its surroundings after necessary debridement. The patients were followed up at regular intervals for at least 6 months. RESULTS: At the end of the 6-month follow-up, the lower limb pain and ulcers had improved significantly in all patients. The mean toe-brachial index had increased from 0.26 to 0.36. One patient died a month after therapy because of causes unrelated to the procedure. Limb salvage was possible in the remaining five patients and they had a pain-free walking distance of 100 m within 6 months. CONCLUSIONS: Limb salvage was possible in all six diabetic patients with Fontaine stage IV CLI following autologous BM MNC injection. The procedure was safe without any adverse outcomes.