BackgroundThere is no curative therapeutic strategy for Burger���s disease.The delivery of autologous progenitor cells into ischemic tissue is emerging as a novel therapeutic option. ObjectiveWe investigated safety and efficacy of autologous implantation of adipose tissue-derived stromal cells(ADSC) in patients with ischaemic limbs because of Buerger���s disease. MethodsA total 6 patients was enrolled. Two patients had a nonhealing ulcer at affected foot. ADSC were isolated from patient���s abdominal adipose tissue. We injected the ADSC (5x106cells/kg) into the calf muscles of the affected limbs. We evaluated a safety of treatment based on NCI-CTCAE grade and efficacy of it based on clinical (treadmill walking distance[TWD], pain free walking distance[PFWD],rest pain, non-healing ulcers) and laboratory(toe-brachial pressure index[TBPI],ankle-brachial pressure index[ABPI], laser doppler, transcutaneous oxygen pressure[TcO2], conventional angiography, CT angiography)parameters after 24 weeks. ResultsNo procedurally related complications or demonstrable side effects occurred at 24weeks. Nonhealing ulcer was disappeared completely in one patients and became smaller and thinner in another patient. Significant improvement of rest pain on VAS score and walking distance was observed in all patients(Baseline vs after 24weeks: VAS[points] 5.8 vs 2.2, p=0.027, TWD[m] 289 vs 492, p=0.028, PFWD[m] 271 vs 452, p=0.028) with resultant limb salvage at 24weeks. Laboratory parameters also showed improvement of ischaemic status(ABPI 0.62 vs 0.69,p=0.027, TBPI 0.58 vs 0.75, p=0.028, TcO2[mmHg] 51.6 vs 60.6,p=0.028,laser doppler[perfusion unit] 0.72 vs 0.94, p=0.028). However, the results of angiography didn���t show a increase in number of visible collateral vessels. ConclusionAutologous implantation of ADSC is safe and effective to reduce rest pain and to improve clinical performance. Thus, it will be a promising and novel therapeutic modality for patients with Buerger���s disease.