This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.
To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGChanges from baseline exogenous insulin dose at different time points post treatment
Time frame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months
C-peptide level
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
HbA1c level
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
titres of islet antigen antibodies
Time frame: 1 month, 3 months, 6 months, 12 months,24 months, 36 months
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