Table 4 Studies reporting use of Granulocyte-colony Stimulating Factor as part of stem cell therapy for diabetic foot ulcers
From: Stem cell therapy for diabetic foot ulcers: a review of preclinical and clinical research
Author | Year | N | G-CSF dose | Duration (days) | Study design | Type of cell | Administration route | Results | Follow-up (months) |
|---|---|---|---|---|---|---|---|---|---|
Kawamura et al. [87] | 2005 | 21* | 5 μg/kg/day | 4 | One group | Autologous PB-MSC | Intramuscular | Improvement of: - Rest pain** - Limb temperature** - Blood flow** 38% amputation | 0.5–21 |
Yang et al. [100] | 2005 | 34* | 450–600 μg/day | 5 | One group | Autologous PB-MSC | Intramuscular | Improvement in: - Pain (87.1%)** - Cool feeling (90.3%)** - Ankle-brachial index (34.3%)** - TcPO2 (42.3%)** - Ulcer healing (40.0%)** | 4 |
Kawamura et al. [99] | 2006 | 59* | 5 μg/kg/day | 4 | One group | Autologous PB-MSC | Intramuscular | Improvement in: - Symptoms (86%) - Skin temperature (53%) 89% amputation rate | 9 |
Mao et al. [84] | 2008 | 54* | 500–600 μg/day | 5 | One group | Autologous PB-MSC | Intramuscular | Improvement in: - Limb pain (P < 0.05) - Coll feeling (P < 0.05) - Intermitted claudication (P < 0.05) - Ankle-brachial index (P < 0.05) - Skin temperature (P < 0.05) - Angiogenesis TcPO2 (42.3%) - Ulcer healing (40.0%) | 6 |
Zhao et al. [83] | 2009 | 15 | 500 μg/day | 3 | One group | Autologous BM-MSC | Intramuscular | 13 patients showed improvement in: - Pain (P < 0.05) - Cold feeling (P < 0.05) - Angiogenesis (P < 0.01) | 6 |
Zhou et al. [88]. | 2010 | 11 | 300 μg/day | 3–4 | One group | Autologous PB-MSC | Intraarterial | 10 out of 11 patients had reduced pain, claudication, local cool-feeling and ulcer significant. Only one patient did not have any improvement | No details |
Dubsky et al. [78] | 2011 | 14 | No details | No details | One group | Autologous BM-MSC and PB-MSC | Intramuscular | Patients showed improvement in: - TcPO2 (P = 0.0005) - Ulcer healing (P = 0.0078) - Pain (P = 0.002) | 6 |
Dubsky et al. [76] | 2013 | 50 | 5–8 μg/kg/day | 6 | Two groups: - Stem cell therapy - Control group | Autologous PB-MSC or BM-MNC | Intramuscular | Cell therapy group showed better: - Amputation rate (P = 0.009) - Ulcer healing (P = 0.0093) | 6 |
Dubsky et al. [75] | 2014 | 84 | 5–8 μg/kg/day | 3–6 | Three groups: - Stem cell therapy -Angioplasty - Control group | Autologous PB-MSC or BM-MNC | Intramuscular | PTA + SCT group showed better - TcPO2 (P < 0.05) - Amputation-free survival (P < 0.05) SCT group showed better - Wound healing in 3 months (P = 0.032), 6 months (P = 0.005), 12 months (P = 0.0013) | 12 |
Tian et al. [70] | 2016 | 61 | 150–300 mg/day | 3–5 | Three randomized groups: - PTA only - SCT only - PTA + SCT | Autologous PB-MSC | Intramuscular and intraarterial | PTA + SCT group showed: - Better total effective rate (P < 0.05) - Lower stenosis recurrence (P < 0.05) | 9 |