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Intra-arterial Allogeneic Mesenchymal Stem Cells for Critical Limb Ischemia are Safe and Efficacious: Report of a Phase I Study

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Abstract

Background

Critical limb ischemia (CLI) caused by peripheral arterial disease is associated with significant morbidity and mortality. This condition is associated with a 30 % amputation rate as well as mortality levels which might be as high as 25 %. There is no pharmacological therapy available, but several reports have suggested that mesenchymal stem cells (MSCs) may be a useful therapeutic option.

Methods

This study, done at a university hospital, evaluated 13 patients for a phase I trial to investigate the safety and efficacy of intra-arterial MSCs in CLI patients. Eight patients with ten affected limbs were recruited for the study. As two patients (three limbs) died of ischemic cardiac events during the 6-month follow-up period, seven limbs were finally evaluated for the study.

Results

There was significant pain relief. Visual analog scale (VAS) scores decreased from 2.29 ± 0.29 to 0.5 ± 0.34 (p < 0.05), ankle brachial pressure index (ABPI) increased significantly from 0.56 ± 0.02 to 0.67 ± 0.021 (p < 0.01), and transcutaneous oxygen pressure (TcPO2) also increased significantly in the foot from 13.57 ± 3.63 to 38 ± 3.47. Similar improvement was seen in the leg as well as the thigh. There was 86 % limb salvage and six of seven ulcers showed complete or partial healing.

Conclusion

It was concluded that intra-arterial MSCs could be safely administered to patients with CLI and was associated with significant therapeutic benefits.

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Acknowledgments

We acknowledge Stempeutics Research Malaysia (SRM) and University of Malaya (UM) for funding this work.

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Authors and Affiliations

  1. Stempeutics Research Malaysia Sdn. Bhd., Technology Park Malaysia, 57000, Kuala Lumpur, Malaysia

    Anjan Kumar Das

  2. Department of Biomedical Imaging, University of Malaya, 50603, Kuala Lumpur, Malaysia

    Basri Johan Jeet Bin Abdullah, S. S. Dhillon & A. Vijanari

  3. Stempeutics Research Pvt Ltd, Akshay Tech Park, Whitefield, Bangalore, 560066, Karnataka, India

    C. H. Anoop & Pawan Kumar Gupta

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  1. Anjan Kumar Das
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  2. Basri Johan Jeet Bin Abdullah
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  3. S. S. Dhillon
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  5. C. H. Anoop
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Correspondence to Anjan Kumar Das.

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Das, A.K., Abdullah, B.J.J.B., Dhillon, S.S. et al. Intra-arterial Allogeneic Mesenchymal Stem Cells for Critical Limb Ischemia are Safe and Efficacious: Report of a Phase I Study. World J Surg 37, 915–922 (2013). https://doi.org/10.1007/s00268-012-1892-6

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  • DOI: https://doi.org/10.1007/s00268-012-1892-6

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