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Updated: May 12, 2026

Preclinical Model of Hind Limb Ischemia in Diabetic Rabbits
Published on: June 2, 2019
[Genic and cellular therapy for peripheral arterial diseases].
D Smadja1, J-S Silvestre, B I Lévy
1Inserm U 765, service d'hématologie biologique, hôpital européen Georges-Pompidou, faculté de pharmacie, université Paris-Descartes, 75006 Paris, France.
Critical limb ischemia, a severe peripheral arterial disease complication, has limited treatment options. Gene and cell therapies show promise for improving lower-limb blood flow, but face challenges with efficacy and safety.
Area of Science:
- Vascular Biology and Regenerative Medicine
- Gene Therapy
- Cell Therapy
Context:
- Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI), particularly in diabetic patients, presenting limited therapeutic options.
- CLI significantly impacts lower-limb perfusion, necessitating innovative treatment strategies.
- Gene and cellular therapies are emerging as potential interventions for CLI.
Purpose:
- To review the clinical trials of gene therapy for CLI, noting reasons for abandonment such as adverse effects and limited efficacy.
- To discuss various stem cell types (endothelial progenitor cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells) used in cell therapy for CLI.
- To highlight challenges in stem cell characterization and report outcomes from key clinical trials.
Summary:
- Gene therapy trials for CLI have largely been discontinued due to significant side effects, modest therapeutic effects, and major risks.
- Cellular therapies utilize diverse stem cell types, including endothelial progenitor cells, mesenchymal stem cells, embryonic stem cells, and induced pluripotent stem cells.
- Clinical trials in cell therapy for CLI face hurdles related to stem cell characterization and have yielded varied results.
Impact:
- Gene therapy for CLI has demonstrated significant safety and efficacy concerns, leading to trial abandonment.
- Cellular therapies offer a promising alternative for CLI, with ongoing research into optimizing stem cell types and delivery methods.
- Further research is crucial to overcome characterization challenges and improve the clinical outcomes of cell-based therapies for critical limb ischemia.
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