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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03943940
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted May 10, 2019
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.
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.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- 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%)
- Pregnant women, planning to become pregnant and lactating women during the study
- 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.
Contact: Phuong Thi-Bich Le, MSc-MD 902742732 ext +84 email@example.com
Contact: StemCellUnit VanHanh firstname.lastname@example.org
Vietnam, Ho Chi Minh
Van Hanh General Hospital
Ho Chi Minh City
Van Hanh General Hospital
Principal Investigator: Phuong Thi-Bich Le, MSc-MD Stem Cell Unit, Van Hanh General Hospital