Table 1 Randomized clinical trials reporting 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 | Study design | Type of cell | Administration route | Results | Follow-up (months) |
|---|---|---|---|---|---|---|---|
Debin et al. [91] | 2008 | 50 | Two groups: - BM-MSC - Local wound treatment | Autologous BM-MSC | Intramuscular and subcutaneous | BM-MSC showed improved: - Rest pain (P < 0.01) - Claudication distance (P < 0.01) - Ulcer healing (P = 0.012) - Ankle-brachial index (P < 0.01) - Angiogenesis (P = 0.01) - Amputation rate (0.040) | 3 |
Chen et al. [81] | 2009 | 40 | Two groups: - BM-MSC - Conventional individualized treatment | Autologous BM-MSC | Intramuscular | BM-MSC showed better: - Blood flow (P = 0.01) | 3 |
Dash et al. [97] | 2009 | 6** | Two groups: - BM-MSC - Local wound treatment | Autologous BM-MSC | Intramuscular | BM-MSC showed better: - Ulcer healing (P < 0.001) | 3 |
Lu et al. [79] | 2011 | 41 | Two groups: - BM-MSC - BM-MNC | Autologous BM-MSC or BM-MNC | Intramuscular | BM-MSC showed better: - Ulcer healing (P = 0.022) - Limb perfusion (P = 0.040) - Ankle-brachial index (P = 0.017) - TcPO2 (P = 0.001) - Magnetic resonance angiography analysis (P = 0.018) No difference in pain relief and amputation rate | 6 |
Jain et al. [98] | 2011 | 48 | Two groups: - BM-MSC - Peripheral blood | Autologous BM-MSC | Injection* and spray | BM-MSC showed better ulcer healing (P < 0.05) | 3 |
Kirana et al. [73] | 2012 | 24 | Two groups: - BM-MSC - Tissue repair cells (TRC) | Autologous BM-MSC | Injection* and intraarterial | - BM-MSC 83% ulcer healing vs TRC 80% ulcer healing - BM-MSC and TRC had better TcPO2 (P = 0.092) - BMC-MSC improved ankle-brachial index (P < 0.10) - Angiogenesis detected in seven of the BM-MSC/TRC groups | 12 |
Xu et al. [72] | 2016 | 127 | Eight groups: - Group A (G-CSF BID 5 μg/kg/day); four subgroups: 4, 5, 6 or 7 days - Group B (G-CSF BID 10 μg/kg/day); four subgroups: 4, 5, 6 or 7 days | Autologous PB-MSC | Injection* and topical* | G-CSF BID 5 μg/kg/day during 5 days is the optimal dose to mobilize EPC in DFU patients All groups reported improvement of life quality, pain, cold sensation, clinical symptoms and ulcer healing | 1–15 |
Qin et al. [71] | 2016 | 53 | Two groups: - Angioplasty - Angioplasty and stem cell therapy | Allogeneic hUC-MSC | Intraarterial and intramuscular | Combination group showed better: - Ankle-brachial index (P < 0.05) - Skin temperature (P < 0.05) - Claudication distance (P < 0.05) - TcPO2 (P < 0.05) | 1–3 |