Table 1 Characteristics of clinical trials included in the systematic review
Author (year) | Country | Subjects | No. of patients | No. of Limbs | Average age (years) | No. of male | Treatment strategy | Follow-up (months) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Treatment | Control | Treatment | Control | Treatment | Control | Treatment | Control | Treatment (type, no., route) | Control | ||||
Tateishi-Yuyama et al. (2002) [22] | Japan | CLI Fontaine III–IV | 22 | 22 | 22 | 22 | – | – | – | – | BMMSCs 1.5 ± 0.6 × 109 IM | No mobilized PBMNCs | 6 |
Huang et al. (2005) [27] | China | DM with CLI Fontaine III–IV | 14 | 14 | 23 | 24 | 71.1 | 70.9 | 9 | 9 | PBMNCs 3 × 109 IM | Conventional therapy | 3 |
Barć et al. (2006) [28] | Poland | CLI | 14 | 15 | 14 | 15 | – | – | – | – | BMMSCs – IM (14 patients) IA (4 patients) | Conventional therapy | 6 |
Arai et al. (2006) [29] | Japan | CLI Fontaine III or IV | 13 | 12 | 13 | 12 | 62 | 68 | 11 | 7 | BMMSCs (1–3) × 109 IM | Conventional therapy | 1 |
Zhang et al. (2007) [30] | China | DF Wagner1–3 | 31 | 30 | 31 | 30 | 13 | 12 | BMMSCs – IM | Conventional therapy | 1 | ||
Lu et al. (2008) [31] | China | DM with CLI FontaineII–IV | 25 | 25 | 25 | 25 | 66.6 | 65.5 | 11 | 15 | BMMSCs 7.32 × 108–5.61 × 109 IM | Conventional therapy | 3 |
Dash et al. (2009) [32] | India | Buerger’s disease and DF (with ulcer) | 12 | 12 | 12 | 12 | – | – | – | – | BM MSC 5.04–7.26 × 106 IM | Conventional therapy | 3 |
Chen et al. (2009) [33] | China | DF Wagner2–4 | 22 | 18 | 22 | 18 | 65.8 | 63.5 | – | – | BM MSC – IM | Conventional therapy | 1 |
Gan et al. (2009) [34] | China | DF Wagner1–4 | 15 | 15 | 28 | 30 | – | – | – | – | BM MSC (1.35–9.36) × 108 IM | Conventional therapy | 3–12 |
Shi et al. (2009) [35] | China | DM with PAD | 25 | 25 | 25 | 25 | 35-75 | 23 | BMSCs – IM | Conventional therapy | 3 | ||
Procházka et al. (2010) [36] | Czech Republic | CLI with foot ulcer | 42 | 54 | 42 | 54 | 66.2 ± 10.6 | 64.1 ± 8.6 | 36 | 42 | ABMSC 0.7–3.83 × 109 IM | Conventional therapy | 3–4 |
Wen and Huang (2010) [37] | China | CLI Fontaine II–V | 30 | 30 | 112 | 60.8 ± 8.6 | 61.7 ± 8.3 | 20 | 19 | PBSCs 3 × 109 IM | Conventional therapy | 3–36 | |
Walter et al. (2011) [38] | Germany | CLI | 19 | 21 | 19 | 21 | 64.4 ± 15 | 64 ± .516 | 16 | 13 | BM MNC 1.53 × 108 IA | Placebo | 3 |
Iafrati et al. (2011) [39] Benoit et al. (2011) [40] | America | CLI Rutherford4–5 | 34 | 14 | 34 | 14 | 72.5 | 65.7 | 23 | 7 | BMAC 3.23 × 109 IM | Placebo | 3–6 |
Powell et al. (2011) [41] Powell et al (2012) [42] | America | CLI | 48 | 24 | 48 | 24 | 69.2 ± 13.2 | 67.3 ± 11.6 | 34 | 14 | Ixmyelocel-T – IM | Placebo | 6–12 |
Lu et al. (2011) [43] | China | DM with CLI | 20 (BMMSCs) 21 (BMMNCs) | 41 | 20 (BMMSCs) 21 (BMMNCs) | 41 | – | – | – | – | BMMSCs 9.3 × 108 BMMNs 9.6 × 108 IM | Placebo | 6 |
Guan et al. (2011) [44] | China | DF Wagner1–4 | 39 | 40 | 78 | 80 | 69 ± 16 | 45 | BM-MNC 1.27~8.95) × 108 IM | Conventional therapy | 6–36 | ||
Jain et al. (2011) [45] | India | chronic lower limb wounds in DM | 25 | 23 | 25 | 23 | 54 | 58 | – | – | BMSCs – IM | Conventional therapy | 3 |
Ozturk et al. (2012) [46] | Turkey | DM with CLI Fontaine III–IV | 20 | 20 | 20 | 20 | 79.9 ± 9.2 | 70.8 ± 8.8 | 16 | 13 | PBMNC 9.92 × 108–1.24 × 109 IM | Conventional therapy | 3 |
Losordo et al. (2012) [47] | America | CLI Rutherfod 4–5 | 7(LD) 9(HD) | 12 | 7(LD) 9(HD) | 12 | 61.8 ± 13.9(LD) 69.7 ± 10.9(HD) | 67.1 ± 14.2 | 5(LD) 8(HD) | 6 | PMCD34+ 0.1/Kg (LD) 1/Kg (HD) IM | Placebo | 12 |
Li et al. (2013) [48] | China | CLI | 29 | 29 | 29 | 29 | 61 ± 9 | 63 ± 10 | 22 | 23 | BM-MNC – IM | Placebo | 6 |
Szabó et al. (2013) [49] | Hungary | Fontaine III-IV | 10 | 10 | 10 | 10 | 60.6 ± 8.9 | 63.0 ± 12.0 | 8 | 5 | VesCell 6.64 × 107 IM | conventional therapy | 3–24 |
Mohammadzadeh et al. (2013) [50] | Iran | DM with CLI | 7 | 14 | 7 | 14 | 63.5 ± 7.8 | 64.2 ± 7.8 | – | – | PBMCs 0.9–1.2 × 109 IM | Placebo | 3 |
Raval et al. (2014) [51] | America | CLI | 7 | 3 | 7 | 3 | 65 | 85 | 6 | 2 | PBCD133+/PLA 5 × 107–4 × 108 IM | Placebo | 12 |
Teraa et al. (2015) [52] | Netherlands | CLI Fontaine IIb-IV | 81 | 79 | 81 | 79 | 69 | 65 | 57 | 51 | BMMNC 6.57 × 108 IA | Placebo | 6 |
Skóra et al. (2015) [53] | Poland | CLI Fontaine IV | 16 | 16 | 16 | 16 | 66.76 | 68.3 | 11 | 10 | BM MNC+VEGF 0.77–3.83 × 109 IM | Pentoxifylline | 3 |
Lu et al. (2016) [54] | China | DM with PAD | 20 | 21 | 20 | 21 | 67.2 | 27 | PBSCs – IM | Conventional therapy | 6 | ||