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

• ClinicalTrials.gov Identifier: NCT03943940
• Recruitment Status: Unknown
• First Posted: May 9, 2019
• Last Update Posted: May 10, 2019
• Sponsor: Van Hanh General Hospital
• Information provided by (Responsible Party): Van Hanh General Hospital

Tracking Information

• First Submitted Date: May 7, 2019
• First Posted Date: May 9, 2019
• Last Update Posted Date: May 10, 2019
• Actual Study Start Date: April 24, 2019
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2019)

• 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
• 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
• Blood glucose level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
  Assess the changes in Blood glucose level after transplantation
• Hemoglobin A1c (HbA1c) level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
  Assess the changes in HbA1C level after transplantation
• Adverse events [ Time Frame: during the course of 6 months ]
  Number of adverse events in both groups

Original Primary Outcome Measures (submitted: May 7, 2019)

• The level of improvement of pancreatic function, based on 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
• The level of improvement of peripheral insulin resistance, based on 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
• Blood glucose level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
  Assess the changes in Blood glucose level after transplantation
• Hemoglobin A1c (HbA1c) level [ Time Frame: enrollment, 1 month, 3 months and 6 months after transplantation ]
  Assess the changes in HbA1C level after transplantation
• Adverse events [ Time Frame: during the course of 6 months ]
  Number of adverse events in both groups

Current Secondary Outcome Measures (submitted: May 7, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• 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: Control
  Standard medicine

Study Arms

• 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.
  Intervention: Biological: BM-MNC and UC-MSC
• Stand medicines
  30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines.
  Intervention: Other: Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 7, 2019): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2020
• Estimated Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Vietnam

Administrative Information

• NCT Number: NCT03943940
• Other Study ID Numbers: TNLS012019-TBG
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Van Hanh General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Van Hanh General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Van Hanh General Hospital
• Verification Date: May 2019