Published online Jul 26, 2023. doi: 10.12998/wjcc.v11.i21.5083
Peer-review started: March 17, 2023
First decision: April 11, 2023
Revised: May 23, 2023
Accepted: June 16, 2023
Article in press: June 16, 2023
Published online: July 26, 2023
Processing time: 131 Days and 22.8 Hours
Progressive pancreatic β cell dysfunction is a fundamental aspect of the pathology underlying type 2 diabetes mellitus (T2DM). Recently, mesenchymal stem cell (MSC) transplantation has emerged as a new therapeutic method due to its ability to promote the regeneration of pancreatic β cells. However, current studies have focused on its efficacy, and there are few clinical studies on its safety.
To evaluate the safety of human umbilical cord (hUC)-MSC infusion in T2DM treatment.
An open-label and randomized phase 2 clinical trial was designed to evaluate the safety of hUC-MSC transplantation in T2DM in a Class A hospital. Ten patients in the placebo group received acellular saline intravenously once per week for 3 wk. Twenty-four patients in the hUC-MSC group received hUC-MSCs (1 × 106 cells/kg) intravenously once per week for 3 wk. Diabetic clinical symptoms and signs, laboratory findings, and imaging findings were evaluated weekly for the 1st mo and then at weeks 12 and 24 post-treatment.
No serious adverse events were observed during the 24-wk follow-up. Four patients (16.7%) in the hUC-MSC group experienced transient fever, which occurred within 24 h after the second or third infusion; this did not occur in any patients in the placebo group. One patient from the hUC-MSC group experienced hypoglycemic attacks within 1 mo after transplantation. Significantly lower lymphocyte levels (weeks 2 and 3) and thrombin coagulation time (week 2) were observed in the hUC-MSC group compared to those in the placebo group (all P < 0.05). Significantly higher platelet levels (week 3), immunoglobulin levels (weeks 1, 2, 3, and 4), fibrinogen levels (weeks 2 and 3), D-dimer levels (weeks 1, 2, 3, 4, 12, and 24), and neutrophil-to-lymphocyte ratios (weeks 2 and 3) were observed in the hUC-MSC group compared to those in the placebo group (all P < 0.05). There were no significant differences between the two groups for tumor markers (alpha-fetoprotein, carcinoembryonic antigen, and carbohydrate antigen 199) or blood fat. No liver damage or other side effects were observed on chest X-ray.
Our study suggested that hUC-MSC transplantation has good tolerance and high safety in the treatment of T2DM. It can improve human immunity and inhibit lymphocytes. Coagulation function should be monitored vigilantly for abnormalities.
Core Tip: Diabetes mellitus is a major public health problem worldwide. Type 2 diabetes mellitus is regarded as a chronic progressive disease that arises from an impairment in the insulin-sensing mechanisms culminating in insulin resistance. Our article focused on the safety of human umbilical cord mesenchymal stem cell infusion for treating type 2 diabetes mellitus. The results suggested that human umbilical cord mesenchymal stem cell treatment can impact human immunity and inhibit lymphocytes. We should pay attention to its influence on coagulation.