Abstract
BackgroundRapidly 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.Methods44 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.ResultsThere 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.ConclusionsFindings 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.
Highlights
Type 1 diabetes mellitus (T1DM) is demonstrated to be caused by an autoimmune mechanism which leads to destruction of β-cells in the pancreas [1]
As stem-cell therapy is not widely applied and considering the novelty of the technique which makes it impossible to conduct extensive follow up studies [13,14], we aimed to conduct a 3-year safety follow-up of patients with diabetes who had undergone fetal liverderived cell suspension allotransplantation in a study done by Ghodsi et al in 2007 [15]
In the 3rd year of follow-up in 2009, 44 of 56 patients who had undergone fetal liver-derived cell suspension allotransplantation or received placebo injection were visited for the assessment of the course of their disease or any other potential life-threatening complications of the transplantation
Summary
Type 1 diabetes mellitus (T1DM) is demonstrated to be caused by an autoimmune mechanism which leads to destruction of β-cells in the pancreas [1]. It is hypothesized that in type 2 diabetes mellitus (T2DM), β cells undergo apoptosis via some obscure immunological mechanisms. There is a need to develop new therapeutic approaches for the treatment of diabetes such as stemcell therapy as well as investigating their long-term safety [9-11]. It is of crucial importance to evaluate the long-term safety of such new therapeutic approaches. 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
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