Adipose-derived stromal vascular fraction (SVF) cells for the treatment of non-reconstructable peripheral vascular disease in patients with critical limb ischemia: A 6-year follow-up showing durable effects.

We previously reported 18-month results post-injection of adipose-derived stromal vascular fraction (SVF) cells in 10 patients with end-stage peripheral vascular disease (PVD) in critical limb ischemia (CLI) and candidates for amputation, secondary to long-standing diabetes and/or arteriosclerotic disease. We documented positive clinical outcomes demonstrating pain relief as a change in the Rutherford score, improvement of ankle-brachial ratios (ABI), complete healing of 6 critical-size ulcers and evidence of neovascularization to the foot by MRI-based angiography. We now report persistency of the effect 6 years post-procedure in five patients and 4 years post-procedure in four additional patients who remained asymptomatic until death due to cardiac causes (patient 3) and lost from the study (patient 1). The 10th patient died early in the study. All treated extremities remain asymptomatic with increased ambulation, no recurrence of ulceration, and doppler color flow imaging at various vascular levels of the extremity demonstrating persistent blood flow and the presence of pulses doppler waveforms in the treated foot. Despite the extent of the disease, the contralateral extremities have not worsened significantly and no new ulcerations have appeared in any of the patients. Collectively, these data demonstrate that SVF injections have a durable long-term benefit forestalling further progression of the disease.