NCT03484741

Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Van Hanh General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	MSC and PRP	MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-04-02
• Last updated: 2018-04-04

Locations

1 site across 1 country: Vietnam