Vnitr Lek 2011, 57(5):451-455

Treatment of critical limb ischemia and diabetic foot disease by the use of autologous stem cells

M. Dubský^1,*, A. Jirkovská¹, R. Bém¹, L. Pagáčová², V. Fejfarová¹, M. Varga³, J. Skibová⁵, Š. Langkramer⁴, E. Syková⁴

¹ Centrum diabetologie IKEM Praha, přednostka prof. MUDr. Terezie Pelikánová, DrSc.

² Pracoviště laboratorních metod IKEM Praha, přednosta prof. MUDr. Antonín Jabor, CSc.

³ Klinika transplantační chirurgie IKEM Praha, přednosta prof. MUDr. Miloš Adamec, CSc.

⁴ Ústav experimentální medicíny AV ČR, v.v.i., ředitelka prof. MUDr. Eva Syková, DrSc.

⁵ Oddělení statistiky IKEM Praha

Aim:
The aim of our study was to assess safety and efectiveness of therapy of critical limb ischaemia by autologous stem cells and evaluation of potential adverse events.

Methods:
Fourteen patients were included into the study (11 men, 3 women, mean age 61.9 ± 9.6 years, mean diabetes duration 23.5 ± 11.1 years, mean glycated hemoglobin 6 ± 1 %). Eight patients were treated by bone marrow stromal cells, 6 patients by peripheral blood progenitor cells after stimulation by filgrastim. The suspension of stem cells was then applied into the muscles of ischemic limbs. We evaluated transcutaneous oxygen tension (TcPO₂), subjective pain sensation assessed by Visual Analog Scale (VAS) and wound healing.

Results:
TcPO₂ significantly increased in all patients from 10 ± 8.7 mm Hg before the treatment to 39.4 ± 9.5 mm Hg after 6 months (p = 0.0005) after stem cell therapy. We also observed significant area defect reduction and pain decrease during the follow-up period. Median of area defect was reduced from 4.3 (0.7 - 31.7) before the treatment to 0.06 (0 - 0.5) cm² after 6 months from the treatment (p = 0.0078). Decrease in rest pain was observed in all patients, mean VAS decreased from 5.3 ± 1.8 to 1.1 ± 1.3 after 6 months (p = 0.002).

Conclusion:
Our study suggests that stem cell therapy of diabetic foot disease is an effective therapeutic option with no adverse events for patients with severe peripehral arterial disease. This treatment leads to increase of transcutanous oxygen tension, improves wound healing and decreases the rest pain.

Keywords: stem cells; diabetic foot; peripheral arterial disease; revascularization

Received: October 6, 2010; Accepted: December 3, 2010; Published: May 1, 2011  Show citation