A preliminary evaluation of efficacy and safety of Wharton’s jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus.April 2014
Introduction
Stem 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. Herewe performed a non-placebo controlled prospective phase I/II study to determine efficacy and safety of WJ-MSC transplantation in T2DM.
Methods
Twenty-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.
Results
WJ-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 transplantion-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.
Conclusions
Our 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 registration
Chinese Clinical Trial Register ChiCTR-ONC-10000985. Registered 23 September 2010