Background: Rapidly increasing prevalence of diabetes throughout the world highlights the importance of looking for new treatment options for the disease such as stem cell therapy. With regard to the increasing attention towards stem-cell therapy as a curative treatment for diabetes in recent years, it is of crucial importance to ensure the safety of this novel therapeutic technique. In this study we aim to evaluate the safety of fetal liver-derived cell suspension allotransplantation in the diabetic patients who had attended a clinical trial in 2007.
Methods: 44 out of a total number of 56 patients who had undergone either fetal liver-derived cell suspension allotransplantation or placebo injection in 2007 (IRCT number: 138811071414 N10) were contacted and recruited for the evaluation of possible complications. Patients were referred to a designated ophthalmologist and cardiologist to be screened for retinopathy and cardiovascular diseases. 24-hour urine was collected and tested for the evaluation of nephropathy; and, neuropathy was assessed by means of neuropathic symptoms and monofilament test.
Results: There were no life-threatening complications nor significant differences in terms of evaluated diabetes complications ( retinopathy, neuropathy, nephropathy and cardiovascular diseases ) between the case and control groups. However, one case of meningioma was reported.
Conclusions: Findings of our study demonstrated that stem cell transplantation can be considered a relatively safe procedure apart from one case of meningioma; it did neither cause any life-threatening complications nor increased the rate of the diabetes micro- and macrovascular complications.
Keywords: Cell therapy; Diabetes mellitus; Fetal stem cell.