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

Van Hanh General Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: BM-MNC and UC-MSC; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03943940

TNLS012019-TBG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

BM-MNC and UC-MSC

Experimental group

Description:

30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion.

Treatment:

Biological: BM-MNC and UC-MSC

Stand medicines

Other group

Description:

30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.

Treatment:

Other: Control