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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943940
Recruitment Status : Unknown
Verified May 2019 by Van Hanh General Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Van Hanh General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Biological: BM-MNC and UC-MSC Other: Control Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Stand medicines
30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.
 Other: Control
Standard medicine


Outcome Measures
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Primary Outcome Measures :
  1. The level of C-peptid and HOMA-β [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in C-peptid and HOMA-β level after transplantation

  2. The level of HOMA-IR and cytokines TNF-α, IL-1β [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation

  3. Blood glucose level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in Blood glucose level after transplantation

  4. Hemoglobin A1c (HbA1c) level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in HbA1C level after transplantation

  5. Adverse events [ Time Frame: during the course of 6 months ]
    Number of adverse events in both groups


Secondary Outcome Measures :
  1. Insulin dose and drug dosage [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in Insulin dose and drug dosage after transplantation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943940


Contacts
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Contact: Phuong Thi-Bich Le, MSc-MD 902742732 ext +84 drbphuong@gmail.com
Contact: StemCellUnit VanHanh tebaogocvanhanh@gmail.com

Locations
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Vietnam
Van Hanh General Hospital Recruiting
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
Contact: Phuong Thi-Bich Le, MSc-MD    902742732 ext +84    drbphuong@gmail.com   
Sponsors and Collaborators
Van Hanh General Hospital
Investigators
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Principal Investigator: Phuong Thi-Bich Le, MSc-MD Stem Cell Unit, Van Hanh General Hospital
More Information
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Responsible Party: Van Hanh General Hospital
ClinicalTrials.gov Identifier: NCT03943940    
Other Study ID Numbers: TNLS012019-TBG
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases