Safety of autologous intramuscular platelet lysate injections in patients with critical limb ischaemia: A pilot, exploratory study.

Background & objectives: Platelet concentrate contains a rich cocktail of growth factors that support growth and proliferation of cells. The primary goal of this study was to investigate the safety of platelet lysate (PL) in patients with critical limb ischaemia (CLI) not suitable for standard revascularization. Data on the preliminary efficacy are also presented. Methods: Seven patients (18-70 yr) with CLI classified in the Rutherford grades 3-5, with history of intermittent claudication for more than eight weeks and were not suitable for standard revascularization, underwent autologous intramuscular injections of PL. These patients were examined physically alongside other parameters such as TcPO2, toe pressure, and ankle brachial index, at baseline and were followed up for 12 months. Results: The procedure was well tolerated with no serious adverse or any adverse events reported during follow up. Although not the primary aim of this report, preliminary data showed significant clinical improvement in Rutherford stage, ankle-brachial index and toe pressure which persisted for a year. Interpretation & conclusions: Intramuscular injection of PL was well tolerated with no major adverse events reported in our study participants. With the observed satisfactory safety data, preliminary efficacy data of PL should be further validated.