A preliminary evaluation of efficacy and safety of Wharton's jelly mesenchymal stem cell transplantation in patients with type 2 diabetes mellitus.
BACKGROUND
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. Here we 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 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.


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.


BACKGROUND
Chinese Clinical Trial Register ChiCTR-ONC-10000985. Registered 23 September 2010.
Xuebin
X
Liu
Pei
P
Zheng
Xiaodong
X
Wang
Guanghui
G
Dai
Hongbin
H
Cheng
Zan
Z
Zhang
Rongrong
R
Hua
Xinxin
X
Niu
Jing
J
Shi
Yihua
Y
An
D002454:Cell Differentiation / Q000502:physiology; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D059631:Wharton Jelly / Q000166:cytology*