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10-year safety follow-up in patients with local VEGF gene transfer to ischemic lower limb.
Gene Ther. 2012 Apr; 19(4):392-5.GT

Abstract

Vascular endothelial growth factor (VEGF)-mediated gene therapy (GT) has shown promising results as a novel method in the treatment of severe cardiovascular diseases. VEGF GT has proved to be safe and well tolerated in short-term studies, but there is only very limited data available on long-term effects. In this study we examined the effects of VEGF GT on patients having received VEGF-A gene transfer for the treatment of symptomatic (that is, claudication or critical lower limb ischemia) peripheral arterial occlusive disease. Out of 54 patients, 25 (46%) were interviewed for this study and 26 (48%) had died during the follow-up. Interviewed patients were treated with adenoviral (n=8, mean age 76 (62.7-90.6) years) or plasmid/liposome (n=8, mean age 84.2 (71.9-94.7) years) vectors compared with a randomized control group (n=10, mean age 80.5 (70.7-88.1) years) using a local balloon catheter device. The follow-up time was 10 years. Causes of death were clarified from hospital records. There were no statistically significant differences between the study groups in the causes of death or in the incidence of cancer (VEGF-Adv 0/10 vs VEGF-p/l 1/8 vs Control 1/7, P=0.5), diabetes (3/10 vs 3/8 vs 2/7, P=1.00) or diabetic retinopathy (0/10 vs 1/8 vs 0/7, P=0.45). In addition, we found no differences in the number of amputations of the treated leg (0/10 vs 3/8 vs 1/7, P=0.17). We conclude that transient VEGF-A-mediated GT did not increase the incidence of cancer, diabetes, retinopathy or any other diseases during the 10-year follow-up time. No significant differences were detected in the number of amputations or causes of death. This study supports our previous findings that local adenovirus and plasmid/liposome-mediated VEGF-A GT is safe and well-tolerated treatment in elderly patients with cardiovascular diseases.

Authors+Show Affiliations

Department of Vascular Surgery, Kuopio University Hospital, Kuopio, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21776026

Citation

Muona, K, et al. "10-year Safety Follow-up in Patients With Local VEGF Gene Transfer to Ischemic Lower Limb." Gene Therapy, vol. 19, no. 4, 2012, pp. 392-5.
Muona K, Mäkinen K, Hedman M, et al. 10-year safety follow-up in patients with local VEGF gene transfer to ischemic lower limb. Gene Ther. 2012;19(4):392-5.
Muona, K., Mäkinen, K., Hedman, M., Manninen, H., & Ylä-Herttuala, S. (2012). 10-year safety follow-up in patients with local VEGF gene transfer to ischemic lower limb. Gene Therapy, 19(4), 392-5. https://doi.org/10.1038/gt.2011.109
Muona K, et al. 10-year Safety Follow-up in Patients With Local VEGF Gene Transfer to Ischemic Lower Limb. Gene Ther. 2012;19(4):392-5. PubMed PMID: 21776026.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 10-year safety follow-up in patients with local VEGF gene transfer to ischemic lower limb. AU - Muona,K, AU - Mäkinen,K, AU - Hedman,M, AU - Manninen,H, AU - Ylä-Herttuala,S, Y1 - 2011/07/21/ PY - 2011/7/22/entrez PY - 2011/7/22/pubmed PY - 2012/6/30/medline SP - 392 EP - 5 JF - Gene therapy JO - Gene Ther VL - 19 IS - 4 N2 - Vascular endothelial growth factor (VEGF)-mediated gene therapy (GT) has shown promising results as a novel method in the treatment of severe cardiovascular diseases. VEGF GT has proved to be safe and well tolerated in short-term studies, but there is only very limited data available on long-term effects. In this study we examined the effects of VEGF GT on patients having received VEGF-A gene transfer for the treatment of symptomatic (that is, claudication or critical lower limb ischemia) peripheral arterial occlusive disease. Out of 54 patients, 25 (46%) were interviewed for this study and 26 (48%) had died during the follow-up. Interviewed patients were treated with adenoviral (n=8, mean age 76 (62.7-90.6) years) or plasmid/liposome (n=8, mean age 84.2 (71.9-94.7) years) vectors compared with a randomized control group (n=10, mean age 80.5 (70.7-88.1) years) using a local balloon catheter device. The follow-up time was 10 years. Causes of death were clarified from hospital records. There were no statistically significant differences between the study groups in the causes of death or in the incidence of cancer (VEGF-Adv 0/10 vs VEGF-p/l 1/8 vs Control 1/7, P=0.5), diabetes (3/10 vs 3/8 vs 2/7, P=1.00) or diabetic retinopathy (0/10 vs 1/8 vs 0/7, P=0.45). In addition, we found no differences in the number of amputations of the treated leg (0/10 vs 3/8 vs 1/7, P=0.17). We conclude that transient VEGF-A-mediated GT did not increase the incidence of cancer, diabetes, retinopathy or any other diseases during the 10-year follow-up time. No significant differences were detected in the number of amputations or causes of death. This study supports our previous findings that local adenovirus and plasmid/liposome-mediated VEGF-A GT is safe and well-tolerated treatment in elderly patients with cardiovascular diseases. SN - 1476-5462 UR - https://www.unboundmedicine.com/medline/citation/21776026/10_year_safety_follow_up_in_patients_with_local_VEGF_gene_transfer_to_ischemic_lower_limb_ L2 - https://doi.org/10.1038/gt.2011.109 DB - PRIME DP - Unbound Medicine ER -