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

NCT03943940 | Unknown Phase 1 DMC

• 1 other identifier: TNLS012019-TBG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Insulin dose and drug dosage

  enrollment, 1 month, 3 months and 6 months after transplantation

Study Arms (2)

BM-MNC and UC-MSC

EXPERIMENTAL

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

Stand medicines

OTHER

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

Other: Control

Interventions

BM-MNC and UC-MSC BIOLOGICAL

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

BM-MNC and UC-MSC

Control OTHER

Standard medicine

Stand medicines

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % ≤ 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Van Hanh General Hospital: lead

Study Sites (1)

Van Hanh General Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Phuong Thi-Bich Le, MSc-MD

  Stem Cell Unit, Van Hanh General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuong Thi-Bich Le, MSc-MD

CONTACT

902742732; drbphuong@gmail.com

StemCellUnit VanHanh

CONTACT

tebaogocvanhanh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: April 24, 2019
• Primary Completion: December 30, 2019
• Study Completion: August 30, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

VN (1)