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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03943940

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted May 10, 2019

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.

  • Condition or Disease:Type 2 Diabetes Mellitus
  • Intervention/Treatment: Biological: BM-MNC and UC-MSC
    Other: Control
  • Phase: 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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: August 2020
Arms and interventions
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
Other: Stand medicines
30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.
Other: Control
Standard medicine
Outcome Measures
  • 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
  • Ages Eligible for Study: 18 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
Contacts

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

Contact: StemCellUnit VanHanh tebaogocvanhanh@gmail.com

Locations

Vietnam, Ho Chi Minh
Van Hanh General Hospital
Ho Chi Minh City

Sponsors and Collaborators

Van Hanh General Hospital

Investigators

Principal Investigator: Phuong Thi-Bich Le, MSc-MD Stem Cell Unit, Van Hanh General Hospital

More Information
  • Responsible Party: Van Hanh General Hospital
  • ClinicalTrials.gov Identifier: NCT03943940 History of Changes
  • Other Study ID Numbers: TNLS012019-TBG
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Diabetes Mellitus Diabetes Mellitus, Type 2