Clinical trial NCT03943940: BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients
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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Van Hanh General Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The level of C-peptid and HOMA-β
timeFrame: enrollment, 1 month, 3 months and 6 months after transplantation
measure: The level of HOMA-IR and cytokines TNF-α, IL-1β
timeFrame: enrollment, 1 month, 3 months and 6 months after transplantation
measure: Blood glucose level
timeFrame: enrollment, 1 month, 3 months and 6 months after transplantation
measure: Hemoglobin A1c (HbA1c) level
timeFrame: enrollment, 1 month, 3 months and 6 months after transplantation
measure: Adverse events
timeFrame: during the course of 6 months
Secondary outcomes:
measure: Insulin dose and drug dosage
timeFrame: enrollment, 1 month, 3 months and 6 months after transplantation
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Van Hanh General Hospital
state: Ho Chi Minh
Study officials:
affiliation: Stem Cell Unit, Van Hanh General Hospital
name: Phuong Thi-Bich Le, MSc-MD
role: PRINCIPAL_INVESTIGATOR
References: