Enhancing Limb Salvage by Non-Mobilized Peripheral Blood Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia†
Pramook Mutirangura MD*, Chanean Ruangsetakit MD*, Chumpol Wongwanit MD*, Khamin Chinsakchai MD*, Yael Porat PhD**, Adina Belleli PhD**, David Czeiger MD***
Affiliation : † ClinicalTrials.gov ID: NCT00523731 * Vascular Surgery Unit, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand ** Theravitae Ltd. Nes Ziona, Israel *** Ben-Gurion University, Beer Sheva, Israel
Background : Stem cell therapy has been proposed to enhance the salvage of critically ischemic limbs.
Objective : Assess the efficacy and safety of the implantation of non-mobilized peripheral blood angiogenic
cell precursors (NMPB-ACPs) in patients with critical limb ischemia (CLI) who were poor candidates for
standard revascularization treatment options.
Material and Method: Six patients with CLI due to the infrapopliteal artery occlusive disease were included
in the present study. Intramuscular injections of NMPB-ACPs were administered in the ischemic limbs. The
efficacy was evaluated by clinical outcomes, ankle brachial index, toe brachial index, and computerized
tomographic angiography.
Results : There was no evidence of local or systemic complication related to the procedure. Five patients
(83.3%) had clinically significant improvement of adequate circulation at the distal limb for the complete
healing. Four of them had complete healing of ischemic ulcers and stumps of toe amputation. However, one
patient with adequate granulation tissue at the stump of the left first toe amputation subsequently suffered from
severe foot infection originating from the other toes and eventually underwent below knee amputation. There
was no improvement of circulation at the distal limb after the administration of NMPB-ACPs in one patient
(16.7%) who eventually underwent major amputation.
Conclusion : The preliminary result of NMPB-ACPs therapy may be safe and provide benefits in the improve-
ment of circulation in patients with CLI. A larger controlled trial is required to ascertain these preliminary
results.
Keywords : Arterial occlusive diseases, Critical illness, Ischemia, Lower extremity, Peripheral blood stem cell transplantation, Stem cells
