Document Detail


Transfection of human HGF plasmid DNA improves limb salvage in Buerger's disease patients with critical limb ischemia.
MedLine Citation:
PMID:  21427651     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
AIM: Hepatocyte growth factor is a potent angiogenic agent. This study investigated the efficacy and safety of intramuscular injection of naked plasmid DNA encoding the human hepatocyte growth factor gene in Japanese patients with Buerger's disease and critical limb ischemia.
METHODS: An open-label clinical study was performed at eight hospitals in Japan from May 2004 to April 2008. Ten patients were enrolled. They had Buerger's disease with ischemic ulcers, were not candidates for revascularization, and were unresponsive to conventional drug therapy. Treatment consisted of 8 injections (total dose: 4 mg) of hepatocyte growth factor plasmid, which were administered into the calf muscles and/or distal thigh muscles of the ischemic limbs under ultrasound guidance. Administration was done twice at an interval of 4 weeks. If there was no improvement after 2 doses, a 3rd dose could be administered. The response to treatment was evaluated from the reduction of ischemic ulcer size.
RESULTS: The size of ischemic ulcers showed a decrease in 6/9 (66.7%) patients and the ulcers healed completely in 5/9 (55.6%) patients after gene therapy. Major amputation was not required. There were no deaths and no major safety concerns.
CONCLUSION: Hepatocyte growth factor gene therapy is safe and effective for critical limb ischemia in patients with Buerger's disease.
Authors:
H Shigematsu; K Yasuda; T Sasajima; T Takano; T Miyata; T Ohta; K Tanemoto; Y Obitsu; T Iwai; S Ozaki; T Ogihara; R Morishita
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  International angiology : a journal of the International Union of Angiology     Volume:  30     ISSN:  1827-1839     ISO Abbreviation:  Int Angiol     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-03-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8402693     Medline TA:  Int Angiol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  140-9     Citation Subset:  IM    
Affiliation:
Department of Vascular Surgery, Tokyo Medical University, Tokyo, Japan - hshige@tokyo-med.ac.jp.
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