Abstract 3319: Autologous Transplantation of Peripheral Blood Mononuclear Cells for Patients with Peripheral Artery Diseases; Long Term Outcomes

Mononuclear cell (MNC) transplantation for peripheral artery diseases (PAD) has become prevalent. However, long-term outcomes of this novel therapeutic strategy have not been documented in details. We had extended the observation period following peripheral blood (PB) MNC transplantation for severe PAD, and obtained clinical data suggesting beneficial yet caution requiring effect of therapeutic neovascularization. Indications for intervention were severe rest pain (36/42, 86%), ischemic ulcer of lower limbs (30/42, 71%), or severe intermittent claudication compromising their ADL (6/42, 14%). Altogether, 42 patients (34 men, 8 women; average age 61 +/− 14 years) underwent 94 transplantations. Sixty seven percents (28/42) of the patients were diagnosed as arteriosclerosis obliterans (ASO), and the remainders were thromboangiitis obliterans (TAO). Co-morbidities included diabetes (21/42 50%) and chronic renal insufficiency treated by dialysis (19/42 45%). Early phase (~6 months) success, defined by improvement in either rest pain, ischemic ulcer, or walking distance, was achieved in 76% (32/42) of the patients. During the long-term follow up (average 30+/− 10 months range 6 –50 months), 85% (17/20) of the responding patients were safe from the relapse of ischemic ulcers, and 89% (23/26) were maintained rest pain free. Limb salvage was 91 % (4/42) at early phase, and 97 % (33/34) during the late follow up period. While there were no major adverse events seen in the TAO patients, 32% (9/28) of the ASO patients had suffered the progression of atherosclerosis in their long term follow-up. There were 11 deaths among 28 ASO patients (39%) in the same period, which were notably associated with the presence of renal insufficiency. In the group of patients undergoing hemo-dialyses, responses to the treatment seemed to correlate with their prognosis, suggesting that improved QOL by the cell therapy may have some good contribution on their survival. In conclusion, PBMNC transplantation for severe PAD is a safe and durable intervention for non-ASO patients without renal failure. However, careful and discrete case selection, in company with stringent follow up of atherosclerosis, is critically advisable for ASO patients with severe renal insufficiency.