Both autologous bone marrow mononuclear cell
and peripheral blood progenitor cell therapies
similarly improve ischaemia in patients with
diabetic foot in comparison with control treatment
M. Dubsky
1,4
*
A. Jirkovska
1
R. Bem
1
V. Fejfarova
1
L. Pagacova
2
B. Sixta
3
M. Varga
3
S. Langkramer
5
E. Sykova
6
E. B. Jude
7
1
Diabetes Centre Prague, Czech Republic
2
Autotransfusion Unit Prague,
Czech Republic
3
Clinic of Transplant Surgery,
Institute for Clinical and
Experimental Medicine Prague,
Czech Republic
4
First Medical Faculty,
Charles University Prague,
Czech Republic
5
Centre for Cell Therapy and
Tissue Repair,
Second Medical Faculty,
Charles University Prague,
Czech Republic
6
Institute of Experimental Medicine,
Czech Academy of Science Prague,
Czech Republic
7
Diabetes Centre,
Tameside General Hospital,
Ashton-Under-Lyne
Lancashire, UK
*Correspondence to: Michal Dubsky,
Videnska 1958/9, 14021 Prague 4,
Czech Republic.
E-mail: michal.dubsky@gmail.com
Abstract
Background The aim of our study was to compare the effect of bone marrow
mononuclear cell and peripheral blood progenitor cell therapies in patients
with diabetic foot disease and critical limb ischaemia unresponsive to revascu-
larization with conservative therapy.
Methods Twenty-eight patients with diabetic foot disease (17 treated by bone
marrow cells and 11 by peripheral blood cell) were included into an active group
and 22 patients into a control group without cell treatment. Transcutaneous oxy-
gen pressure and rate of major amputation, as the main outcome measures, were
compared between bone marrow cells, peripheral blood cell and control groups
over 6 months; both cell therapy methods were also compared by the character-
istics of cell suspensions. Possible adverse events were evaluated by changes of
serum levels of angiogenic cytokines and retinal fundoscopic examination.
Results The transcutaneous oxygen pressure increased significantly (p < 0.05)
compared with baseline in both active groups after 6 months, with no significant
differences between bone marrow cells and peripheral blood cell groups;
however, no change of transcutaneous oxygen pressure in the control group
was observed. The rate of major amputation by 6 months was significantly
lower in the active cell therapy group compared with that in the control group
(11.1% vs. 50%, p = 0.0032), with no difference between bone marrow cells and
peripheral blood cell. A number of injected CD34+ cells and serum levels of
angiogenic cytokines after treatment did not significantly differ between bone
marrow cells and peripheral blood cell.
Conclusions Our study showed a superior benefit of bone marrow cells and
peripheral blood cell treatments of critical limb ischaemia in patients with
diabetic foot disease when compared with conservative therapy. There was
no difference between both cell therapy groups, and no patient demonstrated
signs of systemic vasculogenesis. Copyright © 2013 John Wiley & Sons, Ltd.
Keywords stem cell therapy; diabetic foot; critical limb ischaemia
Introduction
Peripheral arterial disease (PAD) is an important predictor of outcome of ulcer
healing in patients with diabetic foot ulcers and often leads to major amputa-
tions [1]. According to the multicentre EURODIALE study, the rate of major
amputation was significantly higher in patients with PAD in comparison with
RESEARCH ARTICLE
Received: 14 September 2012
Revised: 14 January 2013
Accepted: 15 January 2013
Copyright © 2013 John Wiley & Sons, Ltd.
DIABETES/METABOLISM RESEARCH AND REVIEWS
Diabetes Metab Res Rev 2013; 29: 369–376.
Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/dmrr.2399