Journal «Angiology and Vascular Surgery» • 

2009 • VOLUME 15 • №3

Use of autologous progenitor cells of the bone marrow in treatment of patients with lower-limb atherosclerosis obliterans
(results of a randomized, double-blind, placebo-controlled study)

Korymasov E.A.1, Tyumina O.V.3, Ayupov A.M.2, Kazantsev A.V.2, Rossiev V.A.2, Mikheev G.V.2, Volchkov S.E.3, Toropovskii A.N.3

1) Chair of Surgery of the Institute for Postgraduate Medical Education, Samara State Medical University under the Russian Public Health ministry;
2) Department of Vascular Surgery, Samara Regional Clinical Hospital named after M. I. Kalinin;
3) Clinical Centre of Cell Technologies, Samara, Russia

Presented herein are the outcomes of using autologous progenitor cells of the bone marrow in a total of forty-two male patients suffering from atherosclerosis obliterans of the lower-limb arteries with degree II В of ischaemia according to the classification of A. V. Pokrovsky, preconditioned by involvement of the femoropopliteal-tibial segment with no possibility to perform a reconstructive operation. It was a randomized, double-blind, placebo-controlled study limited by a clinical approbation of the method concerned. Bone marrow was sampled from the crests of the iffac bone. Exflisate was subjected to double centrifugation to obtain the leukocytic fraction of the bone marrow, immune magnetic separation – for obtaining the CD 133+ cells. The patients were subdivided into three groups, each consisting of 14 subjects. Group One patients received autologous progenitor cells CD133+, Group Two patients were given the leukocytic fraction of the marrow (CD34+), and Group Three patients (comparison group) received normal saline as a placebo. The preparations were administered into the muscles of the internal and external surface of the crus. The clinical outcomes were evaluated according to the Rutherford scale and demonstrated that Group One and Group Two patients given the cellular material exhibited a statistically significant improvement of their clinical condition, as compared with the findings obtained in the placebo group (P<0.001, by the Mann-Witney test). Based on the results of the treadmill tests performed after 1, 6 and 12 months, the distance of pain-free walk was noted to statistically significantly increase in Group One and Group Two patients, as compared with those from the placebo group. The proposed method of treatment may be recommended for multicenter clinical trials.

KEY WORDS: chronic lower-limb ischaemia, transplantation of stem cells, bone marrow, precursors of endothelial cells.

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