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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
BM-MNC and UC-MSC
Control
Sponsored by
Van Hanh General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Van Hanh General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BM-MNC and UC-MSC

Stand medicines

Arm Description

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

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

Outcomes

Primary Outcome Measures

The level of C-peptid and HOMA-β
Assess the changes in C-peptid and HOMA-β level 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
Blood glucose level
Assess the changes in Blood glucose level after transplantation
Hemoglobin A1c (HbA1c) level
Assess the changes in HbA1C level after transplantation
Adverse events
Number of adverse events in both groups

Secondary Outcome Measures

Insulin dose and drug dosage
Assess the changes in Insulin dose and drug dosage after transplantation

Full Information

First Posted
May 7, 2019
Last Updated
May 8, 2019
Sponsor
Van Hanh General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03943940
Brief Title
BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Van Hanh General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BM-MNC and UC-MSC
Arm Type
Experimental
Arm Description
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion.
Arm Title
Stand medicines
Arm Type
Other
Arm Description
30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.
Intervention Type
Biological
Intervention Name(s)
BM-MNC and UC-MSC
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard medicine
Primary Outcome Measure Information:
Title
The level of C-peptid and HOMA-β
Description
Assess the changes in C-peptid and HOMA-β level after transplantation
Time Frame
enrollment, 1 month, 3 months and 6 months after transplantation
Title
The level of HOMA-IR and cytokines TNF-α, IL-1β
Description
Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation
Time Frame
enrollment, 1 month, 3 months and 6 months after transplantation
Title
Blood glucose level
Description
Assess the changes in Blood glucose level after transplantation
Time Frame
enrollment, 1 month, 3 months and 6 months after transplantation
Title
Hemoglobin A1c (HbA1c) level
Description
Assess the changes in HbA1C level after transplantation
Time Frame
enrollment, 1 month, 3 months and 6 months after transplantation
Title
Adverse events
Description
Number of adverse events in both groups
Time Frame
during the course of 6 months
Secondary Outcome Measure Information:
Title
Insulin dose and drug dosage
Description
Assess the changes in Insulin dose and drug dosage after transplantation
Time Frame
enrollment, 1 month, 3 months and 6 months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phuong Thi-Bich Le, MSc-MD
Phone
902742732
Ext
+84
Email
drbphuong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
StemCellUnit VanHanh
Email
tebaogocvanhanh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuong Thi-Bich Le, MSc-MD
Organizational Affiliation
Stem Cell Unit, Van Hanh General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Hanh General Hospital
City
Ho Chi Minh City
State/Province
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Thi-Bich Le, MSc-MD
Phone
902742732
Ext
+84
Email
drbphuong@gmail.com

12. IPD Sharing Statement

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

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