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

Type 2 Diabetes Mellitus Clinical Trial

— T2DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943940
• Other study ID #: TNLS012019-TBG
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 24, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2019
• Source: Van Hanh General Hospital
• Contact: Phuong Thi-Bich Le, MSc-MD
• Phone: 902742732
• Email: drbphuong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Vietnam	Van Hanh General Hospital	Ho Chi Minh City	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Van Hanh General Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of C-peptid and HOMA-ß	Assess the changes in C-peptid and HOMA-ß level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Primary	The level of HOMA-IR and cytokines TNF-a, IL-1ß	Assess the changes in HOMA-IR and cytokines TNF-a, IL-1ß level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Primary	Blood glucose level	Assess the changes in Blood glucose level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Primary	Hemoglobin A1c (HbA1c) level	Assess the changes in HbA1C level after transplantation	enrollment, 1 month, 3 months and 6 months after transplantation
Primary	Adverse events	Number of adverse events in both groups	during the course of 6 months
Secondary	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