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. |