TY - JOUR
T1 - Intramuscular vascular endothelial growth factor gene therapy in patients with chronic critical leg ischemia
AU - Shyu, Kou-Gi
AU - Chang, Hang
AU - Wang, Bao Wei
AU - Kuan, Peiliang
N1 - Funding Information:
This study was supported in part by Shin Kong Wu Ho-Su Memorial Hospital and The New Century Health Care Promotion Foundation, Taipei, Taiwan.
Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2003/2/1
Y1 - 2003/2/1
N2 - PURPOSE: We sought to investigate the safety and efficacy of intramuscular gene therapy with vascular endothelial growth factor (VEGF) in patients with chronic critical leg ischemia. METHODS: Gene transfer was performed in 24 limbs of 21 patients with rest pain, some of whom also had nonhealing ischemic ulcers (n = 16) due to occlusive peripheral arterial disease. Between 400 μg and 2000 μg of phVEGF165 (400 μg, n = 2; 800 μg, n = 4; 1200 μg, n = 4; 1600 μg, n = 6; and 2000 μg, n = 8) was injected directly into the muscles of the ischemic limb; the same dose was injected 4 weeks later. The ratio of blood pressures at the ankle and brachial artery was measured before and after treatment. RESULTS: Mean (± SD) plasma levels of VEGF increased significantly from 26 ± 31 pg/mL to 63 ± 56 pg/mL (P <0.005), and the ankle-brachial index improved significantly from 0.58 ± 0.24 to 0.72 ± 0.28 (P <0.001). Magnetic resonance angiography showed qualitative evidence of improved distal flow in 19 limbs (79%). Ischemic ulcers healed or improved markedly in 12 limbs (75%). Rest pain was relieved or improved markedly in 20 limbs (83%). Amputation was performed in two limbs because of wound infection. Complications were limited to transient leg edema in six limbs. CONCLUSION: Intramuscular gene therapy with VEGF165 for patients with chronic critical leg ischemia is safe, feasible, and effective.
AB - PURPOSE: We sought to investigate the safety and efficacy of intramuscular gene therapy with vascular endothelial growth factor (VEGF) in patients with chronic critical leg ischemia. METHODS: Gene transfer was performed in 24 limbs of 21 patients with rest pain, some of whom also had nonhealing ischemic ulcers (n = 16) due to occlusive peripheral arterial disease. Between 400 μg and 2000 μg of phVEGF165 (400 μg, n = 2; 800 μg, n = 4; 1200 μg, n = 4; 1600 μg, n = 6; and 2000 μg, n = 8) was injected directly into the muscles of the ischemic limb; the same dose was injected 4 weeks later. The ratio of blood pressures at the ankle and brachial artery was measured before and after treatment. RESULTS: Mean (± SD) plasma levels of VEGF increased significantly from 26 ± 31 pg/mL to 63 ± 56 pg/mL (P <0.005), and the ankle-brachial index improved significantly from 0.58 ± 0.24 to 0.72 ± 0.28 (P <0.001). Magnetic resonance angiography showed qualitative evidence of improved distal flow in 19 limbs (79%). Ischemic ulcers healed or improved markedly in 12 limbs (75%). Rest pain was relieved or improved markedly in 20 limbs (83%). Amputation was performed in two limbs because of wound infection. Complications were limited to transient leg edema in six limbs. CONCLUSION: Intramuscular gene therapy with VEGF165 for patients with chronic critical leg ischemia is safe, feasible, and effective.
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U2 - 10.1016/S0002-9343(02)01392-X
DO - 10.1016/S0002-9343(02)01392-X
M3 - Article
C2 - 12586226
AN - SCOPUS:0037313811
VL - 114
SP - 85
EP - 92
JO - American Journal of Medicine
JF - American Journal of Medicine
SN - 0002-9343
IS - 2
ER -