Efficacy of autologous cell therapy on limb salvage in patients with chronic limb-threatening ischemia: 16-year single-center experience
Aims
Autologous cell therapy (ACT) could be a treatment option for patients with chronic limb-threatening ischemia (CLTI) when standard vascular intervention is impossible. This study aimed to analyze risk factors affecting therapeutic success and identify patients with diabetes most responsive to ACT.
Methods
In this prospective study, 129 treatments were provided to 118 limbs in 107 no-option CLTI patients with diabetes. Bone marrow was obtained, and stem cells were processed and injected into the calf muscles of the affected limb. After 16 years, we analyzed the influence of baseline factors related to patients (diabetes parameters, comorbidities, medications), limb ischemia (TcPO2 value, Graziani and GLASS classifications), ulcer (descriptions according to Wagner, WIfI, SINBAD and Texas classifications), and infection (the value of CRP, the presence of the osteomyelitis, resistant bacteria and clinical signs of infections). Outcomes were limb salvage (LS) and amputation-free survival (AFS), which were assessed using Cox regression models.
Summary
This study presented ACT as a prospective method of revascularization for no-option CLTI patients. Our results suggest that the best initial clinical status of the patient at the time of stem cell administration is the absence of any signs of infection, and stenosis of FP segments. ACT therapy should be more strictly considered in patients with the presence of severe stages of CKD, hemodialysis and those treated with immunosuppressive therapy. Because most of the amputations have been performed within the first year after the therapy, it is the most important period for reducing major amputation rates and prolonging AFS by close follow-up and aggressive management of risk factors such as infection and poor nutritional status.
https://doi.org/10.1186/s13287-025-04493-1
Published: 15 July 2025
