Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Preliminary Safety and Efficacy Evaluation of Bone Marrow Mononuclear Cells (BM-MNCs) and Umbilical Cord Tissue-derived Mesenchymal Stem Cells (UC-MSC) Infusion for Type 2 Diabetes Mellitus (T2DM) Patients
The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.
Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem
cells are isolated and cultured from umbilical cord tissues.
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and
mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30
patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines,
which would be used as the control group.
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 patient's C-peptid and HOMA-β, HOMA-IR,
cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.
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