A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients

Van Hanh General Hospital1 site in 1 country15 target enrollmentApril 1, 2017

ConditionsType 1 Diabetes Mellitus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Van Hanh General Hospital
Enrollment: 15
Locations: 1
Primary Endpoint: Hemoglobin A1c (HbA1c) level
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.

Detailed Description

Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC). 15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation. 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 patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.

Registry

clinicaltrials.gov

Start Date

April 1, 2017

End Date

November 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Van Hanh General Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:
•At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD.
•Previously diagnosed at a medical facility with Type 1 Diabetes.
•Having evidence of insulin depletion based on the test results during screening.
•Patients treated with fixed insulin dose for at least 3 months.
•Males and females between age 18 and 45 years at the screening.
•Patients able to read, write and understand ICF form

Exclusion Criteria

•Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg.
•Having evidence related to renal dysfunction:
•creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men.
•creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman.
•eGRF \< 40 ml/ min
•Proteinuria \> 300 mg/day
•Having evidence of ketoacidosis at the time of selection.
•Having evidence of ongoing or frequent hypoglycemia.
•Having severe infection
•Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs.