Role of Adipose Derived Stem Cells in Patients with Diabetic Foot Ulcers: Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Few studies to date have investigated the role of adipose derived stem cells (ADSCs) in patients with diabetic foot ulcers (DFU). We aimed to conduct a systematic search of the literature to explore the available evidence behind ADSCs application in patients with DFU to establish if it has any added benefit regarding healing rate and healing time in this cohort of patients. The PubMed and Embase databases were searched for eligible studies. Only randomised controlled trials which investigated the impact of ADSCs alone on the healing of DFU were considered eligible and were included for the review. Reported healing rates, time to healing and procedure related complications were collected and analysed. The initial search resulted in 160 papers. Following duplicate removal, 131 papers were screened for eligibility. Only four trials met the study criteria and were included for the final review and analysis. 97 out of 189 patients who were included in the four studies received ADSCs for treatment of DFU whereas the remaining 92 patients received standard measures (control). The median participant age was 62, predominantly male (72.5%). Complete healing was achieved in 83.5% (n  =  81) of patients in the ADSC group compared to 52% (n  =  48) for patients in the control group at 12 months (OR = 4.8, 95%CI  =  2.25 to 10.24, P < 0.0001). Mean healing time in the ADSC group ranged from 31 to 85 days whereas mean healing time in the control group ranged from 42 to 85 days (Pooled weighted mean difference  =  -10.832856, 95%CI  =  -22.44 to 0.77, P  =  0.0673). No significant procedure related complications were reported in either group. The use of ADSCs in patients with DFU appears to demonstrate improved healing rates. The procedure of ADSC harvest and administration appears to be safe based on the initial reports. Large, randomised trials are needed to establish its role in patients with diabetic foot wounds.