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INTERNATIONAL ANGIOLOGY

A Journal on Angiology


Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 2003 December;22(4):349-55

Copyright © 2003 EDIZIONI MINERVA MEDICA

language: English

Therapeutic angiogenesis for patients with limb ischemia by utilization of fibrin meshwork. Pilot randomized controlled study

Kipshidze N. 1, Kipiani K. 2, Beridze N. 2, Roubin G. 1, Tsapenko M. 1, Shehzad M. Z. 1, Moses J. 1, Kipshidze N. N. 3

1 Lenox Hill Heart and Vascular Institute, Cardiovascular Research Foundation, New York, NY, USA 2 National Center of Angiology and Vascular Surgery, Tblisi, Republic of Georgia 3 Institute of Clinical and Experimental Therapy, Tblisi, Republic of Georgia


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Aim. The aim of this paper is to ­assess the fea­sibil­ity and effi­ca­cy of ­fibrin in induc­ing neo­vas­cu­lar­iza­tion as an angio­gen­ic sub­stance and/or car­ri­er for vas­cu­lar endo­the­lial ­growth fac­tor (VEGF) in ­patients with limb ische­mia.
Meth­ods. Twen­ty-three ­patients with limb ische­mia and ­referred for below the knee ampu­ta­tions were ran­dom­ized for treat­ment: group 1, 7 ­patients ­received only a ­saline injec­tion; group 2, 9 ­received intra­mus­cu­lar injec­tion of ­fibrin and group 3, 7 ­received the ­fibrin com­po­si­tion with defe­rox­a­mine and added VEGF165. The ­fibrin mesh­work was intro­duced into the pop­li­teal area of the dis­eased limbs using a dual ­syringe ­system (1 con­tained throm­bin solu­tion [1 mg, 5000 U] and 1 con­tained fibrino­gen [1 mg, Bax­ter ­Hyland Immu­no] solu­tion). In group 3, Defe­rox­a­mine (100 µg) and 500 µg of VEGF165 were added to the fibrino­gen solu­tion.
­Results. In the con­trol group 5 ­patients had under­gone below the knee ampu­ta­tion at the 3-6 month fol­low-up. Only 1 ­patient from Group 2 had below the knee ampu­ta­tion 5 ­months fol­low­ing ­Fibrin only admin­is­tra­tion. Clin­i­cal improve­ment was noted in all 8 ­patients fol­low­ing ­fibrin admin­is­tra­tion and in all 7 ­patients inject­ed with the ­fibrin mesh­work, defe­rox­a­mine and VEGF com­bi­na­tion.
Con­clu­sion. IM injec­tion of ­fibrin is safe and ­appears to be an effi­cient meth­od to treat limb ische­mia. These find­ings indi­cate that use of ­fibrin may be a novel and sim­ple meth­od for induc­ing ther­a­peu­tic angio­gen­e­sis.

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