Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03484741
• Date of registration: 16/03/2018
• Prospective Registration: No
• Primary sponsor: Van Hanh General Hospital
• Public title: Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
• Scientific title: A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
• Date of first enrolment: April 1, 2017
• Target sample size: 15
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03484741
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Vietnam

Contacts

• Name: Phuong Le, MSc-MD

• Name: Phuong Le, MSc-MD
• Affiliation: Stem Cell Unit, Van Hanh General Hospital

• Name: Phuong Le, MSc-MD

• Name: Ngoc Phan, MSc
• Affiliation: Stem Cell Institute, University of Science Ho Chi Minh City

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Biological: MSC and PRP

Primary Outcome(s)

Fasting blood glucose [Time Frame: every month in the course of 6 months]

Hemoglobin A1c (HbA1c) level [Time Frame: 1 month, 3 months and 6 months after transplantation]

Adverse events [Time Frame: during the course of 6 months]

Secondary Outcome(s)

Insulin dose [Time Frame: during the course of 6 months]

Blood insulin level [Time Frame: every month in the course of 6 months]

C-peptide [Time Frame: every month in the course of 6 months]

Secondary ID(s)

DIME 1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Science Ho Chi Minh City