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.