Abstract / Summary
Abstract Background Diabetic peripheral neuropathy (DPN) is a serious complication of diabetes mellitus that can result in chronic pain and contribute to the development of diabetic foot ulcers (DFU). Patient reports from clinical trials using adipose-derived (AD) stromal vascular fraction cells (SVF) to treat DFU suggested concurrent improvement in DPN. Methods This was an open-label, pilot clinical trial to study the safety and potential clinical benefit of autologous ADSVF administered by local injection to treat DPN. Nine subjects with documented complete loss of protective levels of light touch sensation and vibration were treated. Sensory perception threshold levels (SPT) were measured by Semmes-Weinstein monofilaments while vibration perception threshold levels (VPT) were documented using a Horwell neuroesthesiometer. Eight of the nine subjects also had unilateral non-healing diabetic foot ulcers (DFU) despite standard local wound care for ≥ 3 months. Photos and ulcer size measurements were taken of the DFU. Subjects underwent a limited volume liposuction and then the lipoaspirate underwent enzymatic digestion to generate the autologous SVF cells. Forty million SVF cells (in 60 cc Ringer’s Lactate) were implanted along the pedal arteries, into the dorsum of the foot and into the deep plantar space. Subjects were followed at 4, 12, 24, and 48 weeks for safety, changes in neuropathy, and wound healing. Results There were no severe adverse events related to SVF-treatment during the 48-week follow-up. However, one subject who entered the study with an ischemic toe lesion had progression of ischemia at 4 weeks resulting in extensive loss of plantar surface skin requiring digital amputations. One subject was lost to follow-up after 4 weeks. Perception thresholds improved in all available (7) subjects by 12 weeks. At the end of the study (48 weeks), 3 subjects regained normal levels of SPT, and 6 subjects had regained normal levels of VPT. In addition, wounds up to 32 cm 2 healed after local SVF treatment. Conclusions Local implantation of autologous SVF cells in this small subject population was safe and demonstrated potential clinical benefit for treating DPN. Larger clinical trials are needed to further document ADSVF safety and DPN efficacy. Trial Registration The trial was retrospectively registered in clinicaltrials.gov [NCT07553468].