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Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

Primary Purpose

Type 1 Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

Vietnam

Study Type

Interventional

Intervention

MSC and PRP

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Van Hanh Geral HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC and PRP

Arm Description

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.

Outcomes

Primary Outcome Measures

Fasting blood glucose

Assess the changes in fasting blood glucose level after transplantation

Hemoglobin A1c (HbA1c) level

Assess the changes in HbA1C level after transplantation

Adverse events

Evaluate the safety of therapy by number record of adverse events (AEs)

Secondary Outcome Measures

Insulin dose

Reduction of insulin dose after transplantation

C-peptide

Assess the improvement in C-peptide level after transplantation

Blood insulin level

Assess the changes in blood insulin level after transplantation

Full Information

NCT ID

NCT03484741

First Posted

March 16, 2018

Last Updated

April 2, 2018

Sponsor

Van Hanh General Hospital

Collaborators

University of Science Ho Chi Minh City

1. Study Identification

Unique Protocol Identification Number

NCT03484741

Brief Title

Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Van Hanh General Hospital

Collaborators

University of Science Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSC and PRP

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

MSC and PRP

Intervention Description

MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.

Primary Outcome Measure Information:

Title

Fasting blood glucose

Description

Assess the changes in fasting blood glucose level after transplantation

Time Frame

every month in the course of 6 months

Title

Hemoglobin A1c (HbA1c) level

Description

Assess the changes in HbA1C level after transplantation

Time Frame

1 month, 3 months and 6 months after transplantation

Title

Adverse events

Description

Evaluate the safety of therapy by number record of adverse events (AEs)

Time Frame

during the course of 6 months

Secondary Outcome Measure Information:

Title

Insulin dose

Description

Reduction of insulin dose after transplantation

Time Frame

during the course of 6 months

Title

C-peptide

Description

Assess the improvement in C-peptide level after transplantation

Time Frame

every month in the course of 6 months

Title

Blood insulin level

Description

Assess the changes in blood insulin level after transplantation

Time Frame

every month in the course of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phuong Le, MSc-MD

Phone

(+84)902742732

drbphuong@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stem Cell Unit, Van Hanh General Hospital

tebaogocvanhanh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phuong Le, MSc-MD

Organizational Affiliation

Stem Cell Unit, Van Hanh General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ngoc Phan, MSc

Organizational Affiliation

Stem Cell Institute, University of Science Ho Chi Minh City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Van Hanh Geral Hospital

City

Ho Chi Minh City

State/Province

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phuong Le, MSc-MD

Phone

(+84)902742732

drbphuong@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

Type 1 Diabetes Mellitus

Learn more about this trial

Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

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