219-OR: Comparison of the Impact of Autologous Cell Therapy and Conservative Treatment on Chronic Limb-Threatening Ischemia in Patients with Diabetic Foot: A Randomized Controlled Trial

Background: Autologous cell-therapy (ACT) is a new treatment method for patients with diabetes and no-option chronic limb-threatening ischemia (NO-CLTI). We aimed to assess the impact of ACT on CLTI in comparison with standard treatment (ST) in a randomized controlled trial. Methods: Forty diabetic patients with NO-CLTI were randomized to receive either cell therapy (n=20) or standard conservative therapy (n=16); 4 patients dropped out of the study. After 3 months, those in the ST group were switched to ACT (cell therapy crossover). The effect on ischemia and diabetic foot was assessed by changes in transcutaneous oxygen pressure (TcPO2) and the number of healed patients at 3 months. Amputation rates and amputation-free survival (AFS) were assessed at 3 months and then during 12-month follow-up. Results: TcPO2 increased significantly in the ACT group after 1 and 3 months (both p Conclusions: Our study showed that ACT in patients with no-option CLTI and diabetic foot significantly improved limb ischemia and wound healing when compared to standard conservative therapy, without influencing amputation rates and with a trend to higher 1-year AFS in comparison with delayed ACT treatment in ST group. Disclosure M. Dubsky: None. R. Bem: None. A. Nemcova: None. J. Husakova: None. V. Fejfarova: None. A. Jirkovska: None. K. Sutoris: None. Funding Ministry of Health of the Czech Republic (16-27262A, 00023001)