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Clinical efficacy of allogenic mesenchymal stem cells transplantation in patients with ketosis- onset type 1 diabetes mellitus

Objective 
To observe the efficacy of mesenchymal stem cells (MSCs) transplantation in newly diagnosed patients with ketosis- onset type 1 diabetes mellitus (T1DM), and further evaluate the effects of diabetes duration on the efficacy of MSCs transplantation. 
 
 
Methods 
From January 2009 to January 2012, 10 newly diagnosed patients with ketosis-onset T1DM were enrolled in our study and underwent MSCs transplantation in Department of Endocrinology in Drum Tower Hospital Affiliated to Nanjing University Medical School. Of those patients, 4 cases underwent bone marrow MSCs transplantation and 6 cases underwent umbilical cord MSCs transplantation. The insulin dosage, glycated hemoglobin A1c (HbA1c) and C-peptide levels in those patients were recorded before/after MSCs transplantation. We divided all patients according to diabetes duration (duration ≤1 month (n=4) and duration>1 month (n=6)) for further analysis. The difference in the recorded values among different time points was determined by one- way ANOVA. The effects of diabetes duration on the efficacy were analyzed by the analysis of stratification and covariance. The survival rate of islet function after transplantation was estimated by survival analysis. 
 
 
Results 
After the transplantation, the insulin dosage and HbA1c decreased in different degree, and HbA1c reduced significantly after 6 and 12 months (7.2%±2.1%, 7.2%±1.7% vs 10.3%±3.5%, F=4.435, P 1 month, the reduction of insulin dosage was significantly higher after 6 and 12 month (- 0.40±0.64) vs (0.08±0.23) U·kg-1·d-1, (- 0.50±0.46) vs (0.08±0.17) U·kg-1·d-1,F=7.94, 16.21, both P<0.05) and the increase of 2 h C-P levels was significantly higher after 6 month ((191±258) vs (- 244±276) pmol/L, F=8.69,P<0.05) in the patients with diabetes duration ≤1 month. Moreover, the survival rate of islet function over the course of 12 months was significantly higher in the patients with diabetes duration≤1 month (χ2=3.74, P=0.05). 
 
 
Conclusions 
Allogenic MSCs transplantation can improve glucose homeostasis and reduce insulin dosage in newly diagnosed ketosis- onset T1DM patients. Diabetes duration maybe the key factor affecting the efficacy of MSCs therapy. 
 
 
Key words: 
Diabetes mellitus, type 1; Ketosis-onset; Mesenchymal stem cells; Transplantation