NCT03943940

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Van Hanh General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	BM-MNC and UC-MSC	Autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) under sterile conditions to treat this disease. UC-MSC: 1-2 x 10\^6 cells/kg
OTHER	Control	Standard medicine

Timeline

• Start date: 2019-04-24
• Primary completion: 2019-12-30
• Completion: 2020-08-30
• First posted: 2019-05-09
• Last updated: 2019-05-10

Locations

1 site across 1 country: Vietnam