Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

Phase 1

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: MSC and PRP

• Registration Number: NCT03484741
• Lead Sponsor: Van Hanh General Hospital

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.

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-25
• Status Verified: 2018-04
• Study First Posted: 2018-04-02
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-04
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

• Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism.

• Having abnormalities in red blood cells such as sickle cells disease.

• Using alcohol and/or tobacco.

• Blood clotting disorders (INR > 1.5, PTT >40, PT > 15).

• Taking any anticoagulant.

• Taking systemic steroids.

• Participate in another clinical study involving experimenting drugs and/or medical equipment.

• Patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC and PRP	MSC and PRP	15 patients will be given autologous bone marrow-derived mesenchymal stem cells (BM-MSC) and mesenchymal stem cell from allogeneic umbilical cord tissue (UC-MSC) combined with platelet-rich plasma (PRP) by intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) level	1 month, 3 months and 6 months after transplantation	Assess the changes in HbA1C level after transplantation
Adverse events	during the course of 6 months	Evaluate the safety of therapy by number record of adverse events (AEs)
Fasting blood glucose	every month in the course of 6 months	Assess the changes in fasting blood glucose level after transplantation

Secondary Outcome Measures

Name	Time	Method
Insulin dose	during the course of 6 months	Reduction of insulin dose after transplantation
C-peptide	every month in the course of 6 months	Assess the improvement in C-peptide level after transplantation
Blood insulin level	every month in the course of 6 months	Assess the changes in blood insulin level after transplantation

Trial Locations

Locations (1)

Van Hanh Geral Hospital; 🇻🇳 Ho Chi Minh City, Ho Chi Minh, Vietnam