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Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT03484741
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
University of Science Ho Chi Minh City
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: MSC and PRP Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 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.
Biological: MSC and PRP
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 Measures :
  1. Fasting blood glucose [ Time Frame: every month in the course of 6 months ]
    Assess the changes in fasting blood glucose level after transplantation

  2. Hemoglobin A1c (HbA1c) level [ Time Frame: 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in HbA1C level after transplantation

  3. Adverse events [ Time Frame: during the course of 6 months ]
    Evaluate the safety of therapy by number record of adverse events (AEs)


Secondary Outcome Measures :
  1. Insulin dose [ Time Frame: during the course of 6 months ]
    Reduction of insulin dose after transplantation

  2. C-peptide [ Time Frame: every month in the course of 6 months ]
    Assess the improvement in C-peptide level after transplantation

  3. Blood insulin level [ Time Frame: every month in the course of 6 months ]
    Assess the changes in blood insulin level after transplantation



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484741


Contacts
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Contact: Phuong Le, MSc-MD (+84)902742732 drbphuong@gmail.com
Contact: Stem Cell Unit, Van Hanh General Hospital tebaogocvanhanh@gmail.com

Locations
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Vietnam
Van Hanh Geral Hospital Recruiting
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000
Contact: Phuong Le, MSc-MD    (+84)902742732    drbphuong@gmail.com   
Sponsors and Collaborators
Van Hanh General Hospital
University of Science Ho Chi Minh City
Investigators
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Principal Investigator: Phuong Le, MSc-MD Stem Cell Unit, Van Hanh General Hospital
Principal Investigator: Ngoc Phan, MSc Stem Cell Institute, University of Science Ho Chi Minh City

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Responsible Party: Van Hanh General Hospital
ClinicalTrials.gov Identifier: NCT03484741     History of Changes
Other Study ID Numbers: DIME 1001
DIME 1001 ( Other Identifier: Ministry of Health, Viet Nam )
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 6 months after publication
Access Criteria: Type 1 Diabetes Mellitus

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases