open access

Vol 64, No 2 (2013)
Original papers
Published online: 2013-04-30
Submitted: 2013-05-14
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Transplantation of autologous bone marrow mononuclear cells with VEGF gene improves diabetic critical limb ischaemia

Jan Skóra, Piotr Barć, Artur Pupka, Tomasz Dawiskiba, Krzysztof Korta, Michael Albert, Piotr Szyber
Endokrynologia Polska 2013;64(2):129-138.

open access

Vol 64, No 2 (2013)
Original papers
Published online: 2013-04-30
Submitted: 2013-05-14

Abstract


Introduction: The aim of this study was to assess the safety and efficacy of combined autologous bone marrow mononuclear cell and VEGF165 gene therapy in patients with diabetes mellitus suffering from critical limb ischaemia (CLI).
Material and methods: The administration of mononuclear cells (MNCs) and naked VEGF165 plasmid was performed in 16 limbs of 16 patients with rest pain and ischaemic ulcers due to diabetes. MNCs and plasmid were injected into the muscles of the ischaemic limbs. The levels of VEGF in serum and the ankle-brachial index (ABI) were measured before and after treatment. The Visual Analogue Scale (VAS) was used to evaluate pain sensation. CT angiography was performed before and after three months of therapy.
Results: 0.05) two weeks after therapy. The ABI improved significantly from 0.26 &#177; 0.22 to 0.49 &#177; 0.30 (p < 0.001) three months after therapy. A decrease in rest pain was observed in all patients; mean VAS decreased from 6.3 &#177; 1.4 to 1.2 &#177; 1.1 after three months (p < 0.002). Angiograms showed the development of collateral vessels in 12 limbs. Ischaemic ulcers healed in 12 limbs. Amputation was performed in four patients only, because of advanced wound infection. However, the level of amputations was lowered below knee level in these cases. Complications were limited to transient leg oedema in two patients and fever in two patients.
Conclusions: Intramuscular bone marrow MNCs autotransplantation combined with the administration of phVEGF165 gene is safe, feasible and effective for patients with diabetes and CLI. (Endokrynol Pol 2013; 64 (2): 129&#8211;138)

Abstract


Introduction: The aim of this study was to assess the safety and efficacy of combined autologous bone marrow mononuclear cell and VEGF165 gene therapy in patients with diabetes mellitus suffering from critical limb ischaemia (CLI).
Material and methods: The administration of mononuclear cells (MNCs) and naked VEGF165 plasmid was performed in 16 limbs of 16 patients with rest pain and ischaemic ulcers due to diabetes. MNCs and plasmid were injected into the muscles of the ischaemic limbs. The levels of VEGF in serum and the ankle-brachial index (ABI) were measured before and after treatment. The Visual Analogue Scale (VAS) was used to evaluate pain sensation. CT angiography was performed before and after three months of therapy.
Results: 0.05) two weeks after therapy. The ABI improved significantly from 0.26 &#177; 0.22 to 0.49 &#177; 0.30 (p < 0.001) three months after therapy. A decrease in rest pain was observed in all patients; mean VAS decreased from 6.3 &#177; 1.4 to 1.2 &#177; 1.1 after three months (p < 0.002). Angiograms showed the development of collateral vessels in 12 limbs. Ischaemic ulcers healed in 12 limbs. Amputation was performed in four patients only, because of advanced wound infection. However, the level of amputations was lowered below knee level in these cases. Complications were limited to transient leg oedema in two patients and fever in two patients.
Conclusions: Intramuscular bone marrow MNCs autotransplantation combined with the administration of phVEGF165 gene is safe, feasible and effective for patients with diabetes and CLI. (Endokrynol Pol 2013; 64 (2): 129&#8211;138)
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Keywords

diabetic foot; gene therapy; VEGF; bone marrow mononuclear cells

About this article
Title

Transplantation of autologous bone marrow mononuclear cells with VEGF gene improves diabetic critical limb ischaemia

Journal

Endokrynologia Polska

Issue

Vol 64, No 2 (2013)

Pages

129-138

Published online

2013-04-30

Bibliographic record

Endokrynologia Polska 2013;64(2):129-138.

Keywords

diabetic foot
gene therapy
VEGF
bone marrow mononuclear cells

Authors

Jan Skóra
Piotr Barć
Artur Pupka
Tomasz Dawiskiba
Krzysztof Korta
Michael Albert
Piotr Szyber

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