Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.
Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and
allogeneic umbilical cord tissue (UC-MSC).
15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by
intravenous infusion. They were followed up for 6 months after transplantation.
Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion
or by physician assessments.
The primary endpoint is to assess the improvement of patients' Fasting blood glucose, HbA1C,
C-peptide, and blood insulin level.
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