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

  • Liu X
  • Zheng P
  • Wang X
 et al. 
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Abstract

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. 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. Trial registration. Chinese Clinical Trial Register ChiCTR-ONC-10000985. Registered 23 September 2010. © 2014 Liu et al.; licensee BioMed Central Ltd.

Author-supplied keywords

  • C peptide
  • CD3+ T lymphocyte
  • CD4+ T lymphocyte
  • CD8+ T lymphocyte
  • Cell Differentiation
  • Diabetes Mellitus, Type 2
  • Female
  • Humans
  • Male
  • Mesenchymal Stem Cell Transplantation
  • Middle Aged
  • Prospective Studies
  • Wharton Jelly
  • Wharton jelly
  • adult
  • adverse effects
  • adverse outcome
  • aged
  • article
  • cell differentiation
  • clinical article
  • clinical effectiveness
  • clinical evaluation
  • clinical trial
  • controlled clinical trial
  • controlled study
  • cytology
  • female
  • fever
  • follow up
  • glucose
  • glucose blood level
  • glycosylated hemoglobin
  • headache
  • hematoma
  • human
  • interleukin 10
  • interleukin 1beta
  • interleukin 6
  • intrapancreatic endovascular injection
  • lymphocyte count
  • male
  • mesenchymal stem cell transplantation
  • mesenchymal stroma cell
  • middle aged
  • nausea and vomiting
  • non insulin dependent diabetes mellitus
  • outcome assessment
  • pancreas islet beta cell
  • patient safety
  • phase 1 clinical trial
  • phase 2 clinical trial
  • physiology
  • priority journal
  • procedures
  • procedures concerning cells
  • prospective study
  • therapy effect
  • tumor necrosis factor alpha
  • young adult

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Authors

  • X Liu

  • P Zheng

  • X Wang

  • G Dai

  • H Cheng

  • Z Zhang

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