Nanofat Grafting as a Method of Treating Critical Limb Ischemia

The nano fat grafting procedure in the clinical trial involves the collection of adipose tissue under tumescent anesthesia, which is a technique to swell and firm the targeted area, through a separate puncture in the anterior abdominal wall. Following the collection, the adipose tissue undergoes a process of cannulation to prepare the nano fat. This prepared material is then injected into the tissues of the foot and leg using standard intramuscular injection needles. The injections are performed in various directions to ensure proper distribution of the nano fat. This method does not require additional drug therapy. It leverages the natural growth factors and stem cells present in adipose tissue, aiming to improve blood flow and tissue regeneration in limbs affected by critical ischemia. The unique aspect of this treatment is its focus on using autologous materials, minimizing the risk of rejection and side effects associated with foreign substances.

For the clinical trial, a sham procedure would be designed to mimic the nano fat grafting without providing the actual therapeutic intervention. This involve the patient undergoing a similar process with tumescent anesthesia and making a puncture on the anterior abdominal wall. However, instead of harvesting adipose tissue and preparing nano fat, a placebo solution (such as saline) would be injected using the same intramuscular injection technique. The aim of this sham comparator is to assess the psychological and physiological effects of the nano fat grafting procedure itself, by eliminating the potential therapeutic benefits of the nano fat.