Last updated on May 2019

BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients

Brief description of study

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.

Detailed Study Description

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-, HOMA-IR, cytokines TNF-, IL-1, Blood glucose level, Hemoglobin A1c (HbA1c) level.

Clinical Study Identifier: NCT03943940

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Van Hanh General Hospital

Ho Chi Minh City, Vietnam
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Recruitment Status: Open

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