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Updated: Jul 5, 2026

Preclinical Model of Hind Limb Ischemia in Diabetic Rabbits
Published on: June 2, 2019
[Treatment perspectives for critical limb ischemia: gene and cell therapy]
Elisa Pasqualoni1, Emmanuel Messas, Jean-Noël Fiessinger
1Service de médecine vasculaire - HTA, Hôpital européen Georges Pompidou, F75908 Paris Cedex 15, France.
Abstract:
Critical limb ischemia is associated with a high risk of amputation and death. Several medical options have been tested on patients who cannot be revascularized surgically, but none has shown any effect on the amputation rate at 6 months.Gene and cell therapy intended to stimulate angiogenesis have been tested in phase I and II clinical trials. These innovative approaches appear both feasible and safe. Large randomized clinical trials are necessary to demonstrate their benefits and long-term safety.
Insights
Critical limb ischemia (CLI) poses high amputation and death risks. Gene and cell therapies show promise for stimulating blood vessel growth in non-surgical CLI patients, but large trials are needed to confirm benefits.
Area of Science:
- Vascular biology
- Regenerative medicine
- Clinical trial design
Context:
- Critical limb ischemia (CLI) presents a significant clinical challenge with high rates of amputation and mortality.
- Current therapeutic options for patients with CLI unsuitable for surgical revascularization are limited and have not demonstrated efficacy in reducing amputation rates.
- Gene and cell therapies are emerging as potential strategies to address CLI by promoting angiogenesis.
Purpose:
- To evaluate the feasibility and safety of gene and cell therapies for stimulating angiogenesis in patients with critical limb ischemia.
- To assess the potential of these novel therapeutic approaches in a clinical setting.
Summary:
- Phase I and II clinical trials have investigated gene and cell therapies aimed at promoting angiogenesis in CLI patients.
- These innovative treatments have demonstrated feasibility and safety in early-stage investigations.
- No current medical options effectively reduce the 6-month amputation rate in surgically unrevascularizable CLI patients.
Impact:
- Gene and cell therapies represent a promising avenue for treating critical limb ischemia.
- Further research, particularly large randomized clinical trials, is essential to establish the long-term benefits and safety of these therapies.
- Successful development could lead to improved outcomes and reduced amputation rates for CLI patients.
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