BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients
NCT ID: NCT03943940
Last Updated: 2019-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2019-04-24
2020-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Control
Standard medicine
Interventions
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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
Control
Standard medicine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Van Hanh General Hospital
OTHER
Responsible Party
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Principal Investigators
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Phuong Thi-Bich Le, MSc-MD
Role: PRINCIPAL_INVESTIGATOR
Stem Cell Unit, Van Hanh General Hospital
Locations
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Van Hanh General Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TNLS012019-TBG
Identifier Type: -
Identifier Source: org_study_id
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