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Rivista di Angiologia

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 June;22(2):141-7

lingua: Inglese

Vasogen’s ­immune mod­ula­tion ther­a­py (IMT) ­improves post­is­chem­ic foot skin blood flow and trans­cu­ta­ne­ous pO2 recov­ery rates in ­patients with ­advanced peripheral arterial occlusive disease

Edvins­son L. I. H. 1, Edvinsson M. L. 1, Angus Deveber G. 2

1 Depart­men­t of Inter­nal Med­i­cine, Uni­ver­sity Hos­pi­tal of Lund, Lund, Swe­den
2 Vaso­gen Inc., Mis­si­ssau­ga, Onta­rio, Can­a­da


Aim. ­Vasogen’s ­immune mod­ula­tion ther­a­py (IMT)* ­involves the ex vivo expo­sure of a sam­ple of autol­o­gous blood to 3 oxi­da­tive ­stress fac­tors (heat, an oxi­da­tive envi­ron­ment, and ultra­vi­o­let light), fol­lowed by intra­mus­cu­lar re-injec­tion. The pri­mary objec­tive of this study was to ­assess the ­effect of ­Vasogen’s IMT on skin blood flow in ­patients with symp­to­mat­ic periph­er­al arte­ri­al occlu­sive dis­ease (PAOD).
Meth­ods. In a dou­ble-blind, pla­ce­bo-con­trolled pilot study, 18 ­patients with mod­er­ate­ly ­advanced PAOD were ran­dom­ized to ­receive 2 cours­es each of 6 intra­mus­cu­lar injec­tions of ­either ­saline or ­Vasogen’s IMT over a 9-week peri­od. Dor­sal foot skin blood flow was ­assessed direct­ly using laser Dop­pler flux­me­try (LDF) and indi­rect­ly using meas­ure­ment of trans­cu­ta­ne­ous pO2 (tcpO2). Key out­come meas­ures of skin blood flow were, for LDF: rest­ing val­ues, peak post­is­chem­ic val­ues, and the total time to reach peak val­ues fol­low­ing ­release from 4 min of total foot ische­mia and, for tcpO2: rest­ing val­ues and the time for tcpO2 to reach 50% of the pre­-is­che­mia value. Meas­ure­ments were car­ried out at base­line, at weeks 3, 6, and 9, and at 2 ­months post-ther­a­py.
­Results. No sig­nif­i­cant dif­fer­enc­es were detect­ed ­between ­groups for rest­ing or peak post­is­chem­ic LDF val­ues for dor­sal foot skin blood flow. ­Patients ran­dom­ised to IMT expe­ri­enced a pro­gres­sive ­decrease in the time to peak post­is­chem­ic skin blood flow, reach­ing sta­tis­ti­cal sig­nif­i­cance at 2 ­months. Treat­ed ­patients expe­ri­enced a 26.1 s ­decrease in time to peak blood flow (p=0.026) vs a 7.9 s ­decrease in the pla­ce­bo group (p=ns). Sim­i­lar but less strik­ing ­results were ­achieved for tcpO2 recov­ery time to 50% of pre-­is­che­mia val­ues (treat­ed group, p=0.035; pla­ce­bo group, p=ns).
Con­clu­sion. ­Vasogen’s IMT ­improved recov­ery rates of post­is­chem­ic dor­sal foot skin blood flow in a group of ­patients with mod­er­ate­ly ­advanced PAOD, prob­ably due to ­improved endo­the­lial func­tion.

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