AIMS: To identify better cells for the treatment of diabetic critical limb ischemia (CLI) and foot ulcer in a pilot trial. METHODS: Under ordinary treatment, the limbs of 41 type 2 diabetic patients with bilateral CLI and foot ulcer were injected intramuscularly with bone marrow mesenchymal stem cells (BMMSCs), bone marrow-derived mononuclear cells (BMMNCs), or normal saline (NS). RESULTS: The ulcer healing rate of the BMMSC group was significantly higher than that of BMMNCs at 6 weeks after injection (P=0.022), and reached 100% 4 weeks earlier than BMMNC group. After 24 weeks of follow-up, the improvements in limb perfusion induced by the BMMSCs transplantation were more significant than those by BMMNCs in terms of painless walking time (P=0.040), ankle-brachial index (ABI) (P=0.017), transcutaneous oxygen pressure (TcO(2)) (P=0.001), and magnetic resonance angiography (MRA) analysis (P=0.018). There was no significant difference between the groups in terms of pain relief and amputation and there was no serious adverse events related to both cell injections. CONCLUSIONS: BMMSCs therapy may be better tolerated and more effective than BMMNCs for increasing lower limb perfusion and promoting foot ulcer healing in diabetic patients with CLI.
RCT Entities:
AIMS: To identify better cells for the treatment of diabetic critical limb ischemia (CLI) and foot ulcer in a pilot trial. METHODS: Under ordinary treatment, the limbs of 41 type 2 diabeticpatients with bilateral CLI and foot ulcer were injected intramuscularly with bone marrow mesenchymal stem cells (BMMSCs), bone marrow-derived mononuclear cells (BMMNCs), or normal saline (NS). RESULTS: The ulcer healing rate of the BMMSC group was significantly higher than that of BMMNCs at 6 weeks after injection (P=0.022), and reached 100% 4 weeks earlier than BMMNC group. After 24 weeks of follow-up, the improvements in limb perfusion induced by the BMMSCs transplantation were more significant than those by BMMNCs in terms of painless walking time (P=0.040), ankle-brachial index (ABI) (P=0.017), transcutaneous oxygen pressure (TcO(2)) (P=0.001), and magnetic resonance angiography (MRA) analysis (P=0.018). There was no significant difference between the groups in terms of pain relief and amputation and there was no serious adverse events related to both cell injections. CONCLUSIONS: BMMSCs therapy may be better tolerated and more effective than BMMNCs for increasing lower limb perfusion and promoting foot ulcer healing in diabeticpatients with CLI.
Authors: Giovanni Marfia; Stefania Elena Navone; Clara Di Vito; Nicola Ughi; Silvia Tabano; Monica Miozzo; Carlo Tremolada; Gianni Bolla; Chiara Crotti; Francesca Ingegnoli; Paolo Rampini; Laura Riboni; Roberta Gualtierotti; Rolando Campanella Journal: Organogenesis Date: 2015 Impact factor: 2.500