Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence?

Mol Diagn Ther. 2023 Nov;27(6):673-683. doi: 10.1007/s40291-023-00667-w. Epub 2023 Sep 22.

Abstract

This current opinion article critically evaluates the efficacy of autologous cell therapy (ACT) for chronic limb-threatening ischemia (CLTI), especially in people with diabetes who are not candidates for standard revascularization. This treatment approach has been used in 'no-option' CLTI in the last two decades and more than 1700 patients have received ACT worldwide. Here we analyze the level of published evidence of ACT as well as our experience with this treatment method. Many studies have shown that ACT is safe and an effective method for patients with the most severe lower limb ischemia. However, some trials did not show any benefit of ACT, and there is some heterogeneity in the types of injected cells, route of administration and assessed endpoints. Nevertheless, we believe that ACT plays an important role in a comprehensive treatment of patients with diabetic foot and severe ischemia.

Trial registration: ClinicalTrials.gov NCT03968198 NCT04466007 NCT04661644.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amputation, Surgical
  • Cell- and Tissue-Based Therapy
  • Diabetes Mellitus*
  • Diabetic Foot* / therapy
  • Humans
  • Ischemia / etiology
  • Ischemia / therapy
  • Retrospective Studies
  • Risk Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03968198
  • ClinicalTrials.gov/NCT04466007
  • ClinicalTrials.gov/NCT04661644