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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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