Trial name/Author Year Study design Number of patients Product Route of administration Follow-up duration Outcomes
Total Treated Control
Kim et al. [74] 2006 Patient series 4 4 0 HLA matched
UCB-derived MSCs
SC or IM 4 months Rest pain ↑swithin 14 days,
Wound healing ↑uwithin 120 days,
Angiographic collateral vessels ↑
Dash et al. [75] 2009 RCT 24 12 12 BM-MSCs IM 12 weeks Pain-free walking distance ↑,
Ulcer size ↓
Lu et al. [77] 2011 RCT
double-
blind
41
(82 limbs)
41 limbs 41limbs BM-MSCs
(20 limbs)
BM-MNCs
(21 limbs)
IM 24 weeks BM-MSCs vs Control
ABPI ↑, TcPO2 ↑,
Rest pain scale ↓,
Pain-free walking time ↑,
Angiographic score ↑,
Ulcer healing ↑
BM-MSC vs BM-MNCs
ABPI ↑, TcPO2 ↑,
Rest pain scale ↓,
Pain-free walking time ↑,
Angiographic score ↑,
Ulcer healing ↑,
Rest pain scale →,
Amputation rate →
Lasala et al. [108] 2010 Patient series 10 10 0 BM-MSCs
+BM-MNCs
IM 10 months Total walking time ↑,
ABPI ↑, QOL ↑
Lasala et al. [76] 2012 Patient series 26 26 limbs 26 limbs BM-MSCs
+BM-MNCs
IM 4 months ABPI ↑,
Total walking time ↑,
QOL ↑,
Scintigraphic limb perfusion ↑
RESTORE-CLI
Powell et al. [79]
2011 RCT 46 32 14 Ixmyelocel-T IM 6 months
12 months
Amputation-free suivival ↑
Ulcer healing ↑
ACellDREAM
Bura et al. [88]
2014 Patient series 7 7 0 ADSCs IM 6 months TcPO2
Ulcer healing ↑
ADSC indicates adipose-derived stem cell; HLA, human leukocyte antigen; MSC, mesenchymal stem cell; SC, subcutaneous; UCB, umbilical cord blood.
Table 5: Clinical trials of MSCs for CLI.