BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients (T2DM)

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Biological: BM-MNC and UC-MSC; Other: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Phuong Thi-Bich Le, MSc-MD; Phone Number: +84 902742732; Email: drbphuong@gmail.com
• Study Contact Backup: Name: StemCellUnit VanHanh; Email: tebaogocvanhanh@gmail.com

Study Locations

• Vietnam
  • Ho Chi Minh
    • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
      • Recruiting
      • Van Hanh General Hospital
      • Contact: Phuong Thi-Bich Le, MSc-MD; Phone Number: +84 902742732; Email: drbphuong@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more
• Patients are able to read, write and understand ICF form and agree to participate in the study
• Males and females between age 18 and 70 years at the screening.
• FBG > 7 mmol/L
• 8% ≤ HbA1C ≤ 11%
• Fasting C-peptide > 0.6 ng/ml
• Anti GAD (-)
• The patient is treated by two oral diabetes medications but uncontrolled blood glucose (HbA1C ≥ 8%)

Exclusion Criteria:

• Pregnant women, planning to become pregnant and lactating women during the study period
• The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease;
• Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO;
• Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia
• Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days
• Hematologic disease or coagulopathy
• There are abnormalities in liver function (AST and/or ALT ≥ 2 times or bilirubin ≥ 2.0 times normal value at the time of screening);
• Patients with immunodeficiency diseases such as HIV or hepatitis B and C;
• Acute or chronic pancreatitis or a history of acute pancreatitis;
• Patients taking immunosuppressive drugs (such as azathioprine, methotrexate) within 6 months before the study time or taking immunosuppressive drugs;
• The patient is unable to complete the study;
• The patient is participating in another study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BM-MNC and UC-MSC; 30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion.	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: Stand medicines; 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.	Other: Control; Standard medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of C-peptid and HOMA-β	Assess the changes in C-peptid and HOMA-β level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
The level of HOMA-IR and cytokines TNF-α, IL-1β	Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Blood glucose level	Assess the changes in Blood glucose level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Hemoglobin A1c (HbA1c) level	Assess the changes in HbA1C level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Adverse events	Number of adverse events in both groups	during the course of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin dose and drug dosage	Assess the changes in Insulin dose and drug dosage after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation

Collaborators and Investigators

• Sponsor: Van Hanh General Hospital
• Investigators: Principal Investigator: Phuong Thi-Bich Le, MSc-MD, Stem Cell Unit, Van Hanh General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TNLS012019-TBG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No