2014 Volume 54 Issue 8 Pages 115-122
In 2003, we started a phase I/IIa clinical trial regarding the intramuscular transplantation of granulocyte colony stimulating factor-mobilized CD34+ cells in 17 patients with critical limb ischemia (CLI). No major amputation occurred and the CLI-free ratio was as high as 88%, one year post cell therapy. Ulcer area, toe brachial pressure index, and walking distance significantly improved after the treatment. We confirmed the long-term efficacy and safety of this cell therapy up to 4 years. From 2008, we performed the first investigator-led clinical trial under good clinical practice in the field of regenerative medicine in Japan. Favorable outcomes in terms of safety and efficacy were reproduced in this phase II trial. We are now preparing for the phase III, pivotal trial for pharmaceutical approval of the cell-based vascular regeneration therapy.
