A preliminary evaluation of efficacy and safety of Wharton’s jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus

Abstract

IntroductionStem cell therapy has recently been introduced to treat patients with type 2 diabetes mellitus (T2DM). However, no data are available on the efficacy and safety of allogeneic Wharton’s Jelly-derived mesenchymal stem cell (WJ-MSC) transplantation in patients with T2DM. Here we performed a non-placebo controlled prospective phase I/II study to determine efficacy and safety of WJ-MSC transplantation in T2DM.MethodsTwenty-two patients with T2DM were enrolled and received WJ-MSC transplantation through one intravenous injection and one intrapancreatic endovascular injection (catheterization). They were followed up for 12 months after transplantation. The primary endpoints were changes in the levels of glycated hemoglobin and C-peptide and the secondary endpoints included insulin dosage, fasting blood glucose (FBG), post-meal blood glucose (PBG), inflammatory markers and T lymphocyte counts.ResultsWJ-MSC transplantation significantly decreased the levels of glucose and glycated hemoglobin, improved C-peptide levels and beta cell function, and reduced markers of systemic inflammation and T lymphocyte counts. No major WJ-MSC transplantation-related adverse events occurred, but data suggest a temporary decrease in levels of C-peptide and beta cell function at one month after treatment, possibly related to intrapancreatic endovascular injection.ConclusionsOur data demonstrate that treatment with WJ-MSCs can improve metabolic control and beta cell function in patients with T2DM. The therapeutic mechanism may involve improvements in systemic inflammation and/or immunological regulation.Trial registrationChinese Clinical Trial Register ChiCTR-ONC-10000985. Registered 23 September 2010

Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients with Diabetic Retinopathy

“…Therefore, we selected IL-6 to assess the function of MSCs after transplantation. In support of previous research [30], IL-6 levels increased with time, accompanied by CRP reductions. CRP is a nonspecific sensitive index reflecting the state of inflammation; its level is positively correlated with the development of DR [33].…”

“…Most DR clinical trials conducted to date have focused on improving local circulation and metabolism, while ignoring the improvement in general condition [8,26,28]. Moreover, previous trials investigating MSC for patients with DR did not report retinal changes, although most showed an improvement in glucose metabolism [16,29,30]. Herein, we describe the outcomes of ABMSC transplantation in patients with DR, including changes in glucose metabolism, immune function, visual function, and retina microcirculation.…”

Expanded autologous adipose derived stem cell transplantation for type 2 diabetes mellitus

“…In the previous clinical trials, using Wharton's jelly derived MSCs, Liu et al (2014) showed that MSC transplantation significantly decreased the levels of glucose and glycated hemoglobin, while improving C-peptide levels and beta cell function (Liu et al, 2014). In another study, Jiang et al (2011) (Jiang et al, 2011).…”

“…After the transplantation, Tong et al showed that C-peptide levels increased in all of the patients; in fact reduced insulin dose corresponded with improved C-peptide levels (Tong et al, 2013). In 2014, 22 patients with T2D were treated with Wharton's jelly derived MSC (WJ-MSC) transplantation through intravenous injection and intra-pancreatic endovascular injection (Liu et al, 2014). Liu et al showed that WJ-MSC transplantation significantly decreased the levels of glucose, improved C-peptide levels, and improved beta cell function, all without any adverse effects (Liu et al, 2014).…”

“…In 2014, 22 patients with T2D were treated with Wharton's jelly derived MSC (WJ-MSC) transplantation through intravenous injection and intra-pancreatic endovascular injection (Liu et al, 2014). Liu et al showed that WJ-MSC transplantation significantly decreased the levels of glucose, improved C-peptide levels, and improved beta cell function, all without any adverse effects (Liu et al, 2014). , Hu et al (2016 reported the long-term efficacy and safety of infusion of WJ-MSC on T2D in a study of61 patients with T2DM.…”