Trial name/Author Year Study design Number of patients Product Route of administration Follow-up duration Outcomes Total Treated Control Kawamoto et al.  [59] Kinoshita et al. [60] 2009 Patient series 17 17 0 G-CSF-mobilized CD34+ cells IM 52 weeks Efficacy score (TBPI, Rest pain scale, Total walking distance) ↑ ACT34-CLI Losordo et al. [62] 2012 RCT double- blind 28 16 12 G-CSF-mobilized CD34+ cells IM 12 months Amputation rate ↓ (p=0.058) compared with control Fujita et al. [61] 2014 Patient series 11 11 0 G-CSF-mobilized CD34+ cells IM 52 weeks Rutherford’s category ↑, Rest pain scales ↓, Skin perfusion pressure ↑, TBPI ↑, TcPO2 ↑, Pain-free walking distance ↑, Total walking distance ↑ Burt et al. [63] 2010 Patient series 9 9 0 G-CSF-mobilized CD133+ cells IM 12 months QOL ↑ (at 6 months) Perin et al. [67] 2011 RCT 21 21 0 ALDHbr (n=11) BM-MNCs (n=10) IM 12 weeks Rutherford’s category ↓, ABPI ↑ in the ALDHbr treated group. ALDHbr indicates aldehyde dehydrogenase bright; EPCs, endothelial progenitor cells; TBPI, toe brachial pressure index.

Table 4: Clinical trials of fractionated EPCs (CD34+/ CD133+/ ALDHbr cells) therapy for CLI.