Trial name/Author Year Study design Number of patients Route of administration Follow-up duration Outcomes Total Treated Control TACT Tateishi-Yuyama et al. [46] 2002 Patient series RCT 45 45 25 BM-MNCs 20 PB-MNCs 0 IM 24 weeks ABPI ↑, TcPO2 ↑, Pain-free walking time ↑ Higashi et al. [93] 2004 Patient series 7 7 0 IM 4 weeks TcPO2↑, Pain-free walking time ↑, Blood flow response to acetylcholine↑ Miyamoto et al. [94] 2006 Patient series 8 8 0 IM 2 years Rest pain scale↓, Ulcer healing↑ (at 4 weeks) Sudden death (n=1), Skin ulcer (n=1), Rest pain (n=1), Arteriovenous shunt (n=1) (Long-term) Motukuru et al. [95] 2008 Patient series 36 36 0 IM 6 months ABPI↑, TcPO2↑, Ulcer healing↑ De Vriese et al. [96] 2008 Patient series 16 16 0 IM 12 weeks ABPI→, TcPO2↑, Rest pain scale↓, Muscle capillary density↑ Cobellis et al. [97] 2008 Patient series 10 10 0 IA 12 months ABPI↑, Pain-free walking distance↑, Rest pain scale↓, Blood flow↑, Capillary density↑ Chochola et al. [98] 2008 Patient series 24 24 0 IM 1 year Fontaine grade↓, Ulcer healing↑, Collateral vessel↑, QOL↑ Franz et al. [99] 2009 Patient series 9 9 0 IM+IA 3 months ABPI →, Rest pain scale →, Limb salvage → BONMOT-1 Amman et al. [100] 2009 Patient series 51 51 0 IM 6 months Rutherford’s category↓, ABPI↑, TcPO2↑,  Ulcer healing↑, Total walking distance↑ Prochazka et al. [101] 2010 RCT non- blinded 96 42 54 IA 120 days Limb salvage↑, PROVASA Walter et al. [48] 2011 RCT double- blind crossover 40 19 21 IA 6 months Ulcer healing↑, Rest pain scale↓, ABPI →, Limb salvage → Ruiz-Salmeron et al. [102] 2011 Patient series 20 20 0 IA 12 months ABPI↑, Wound healing↑,  Angiographic blood flow ↑ (at 3 months) Murphy et al. [103] 2011 Patient series 29 29 0 IM 1 year FTP↑, TBPI↑, Rest pain scale↓, QOL↑ (at 12 weeks) Idei et al. [104] 2011 Cohort 97 51 46 IM 3 years Amputation-free survival↑ ABPI↑, TcPO2↑in patients with TAO. ABPI→, TcPO2→ in patients with Atherosclerotic PAD. Benoit et al. [105] 2011 RCT double- blind 48 34 14 IM 6 months Amputation rate↓ Klepanec et al. [106] 2012 Patient series 41 41 0 IM (n=21), IA (n=20) 6 months Rutherford’s category↓, TcPO2↑, Rest pain scale↓, QOL↑ ABPI indicates ankle brachial pressure index; BM, bone marrow; CLI, critical limb ischemia; FTP, first toe pressure; IA, intra-arterial; IM, intramuscular; MNC, mononuclear cell; PAD, peripheral arterial disease; PB, peripheral blood; QOL, quality of life; RCT, randomized controlled trial; TAO, thromboangitis obliterance; TcPO2, transcutaneous oxygen pressure.

Table 1: Clinical trials of autologous BM-MNC administration for CLI.