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Updated: Feb 22, 2026
Embryonic Stem Cell-Derived Endothelial Cells for Treatment of Hindlimb Ischemia
Published on: January 23, 2009
Stem cell-based peripheral vascular regeneration
Yasuyuki Fujita1, Atsuhiko Kawamoto1
1Division of Vascular Regeneration, Unit of Regenerative Medicine, Institute of Biomedical Research and Innovation, Foundation for Biomedical Research and Innovation, Japan; Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Japan.
Insights
Stem cell therapies show promise for critical limb ischemia (CLI), an advanced stage of peripheral arterial disease (PAD). While early trials suggest safety and efficacy, more late-phase studies are needed to confirm benefits for patients ineligible for traditional treatments.
Area of Science:
- Regenerative Medicine
- Vascular Biology
- Cell-Based Therapies
Background:
- Chronic critical limb ischemia (CLI) is an advanced stage of peripheral arterial disease (PAD), carrying high risks of amputation and mortality.
- Many CLI patients cannot undergo conventional revascularization, necessitating alternative strategies to restore blood flow.
Purpose of the Study:
- To review preclinical and clinical evidence on cell-based therapies for CLI.
- To assess the utility and limitations of stem/progenitor cell applications in treating CLI.
Main Methods:
- Review of preclinical research and clinical trial data.
- Analysis of studies focusing on proangiogenic therapies, including gene/protein therapy and stem/progenitor cells.
Main Results:
- Somatic stem/progenitor cells, such as bone marrow-derived endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs), have emerged as promising therapeutic options.
- Early-phase clinical trials indicate that stem/progenitor cell therapies are potentially safe, feasible, and effective for CLI.
Conclusions:
- Cell-based therapies represent a significant advancement in therapeutic angiogenesis for CLI.
- Further late-phase clinical trials are essential to validate the long-term efficacy and fully understand the limitations of these innovative treatments.
Abstract:
Chronic critical limb ischemia (CLI) represents an end-stage manifestation of peripheral arterial disease (PAD). CLI patients are at very high risk of amputation and cardiovascular complications, leading to severe morbidity and mortality. Because many patients with CLI are ineligible for conventional revascularization procedures, it is urgently needed to explore alternative strategies to improve blood supply in the ischemic tissue. Although researchers initially focused on gene/protein therapy using proangiogenic growth factors/cytokines, recent discovery of somatic stem/progenitor cells including bone marrow (BM)-derived endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs) has drastically developed the field of therapeutic angiogenesis for CLI. Overall, early phase clinical trials demonstrated that stem/progenitor cell therapies may be safe, feasible and potentially effective. However, only few late-phase clinical trials have been conducted. This review provides an overview of the preclinical and clinical reports to demonstrate the usefulness and the current limitations of the cell-based therapies.
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