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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

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE April 2, 2018
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Fasting blood glucose [ Time Frame: every month in the course of 6 months ]
    Assess the changes in fasting blood glucose level after transplantation
  • Hemoglobin A1c (HbA1c) level [ Time Frame: 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in HbA1C level after transplantation
  • Adverse events [ Time Frame: during the course of 6 months ]
    Evaluate the safety of therapy by number record of adverse events (AEs)
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2018)
Adverse events [ Time Frame: during the course of 6 months ]
Evaluate the safety of therapy by number record of adverse events (AEs)
Change History Complete list of historical versions of study NCT03484741 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2018)
  • Insulin dose [ Time Frame: during the course of 6 months ]
    Reduction of insulin dose after transplantation
  • C-peptide [ Time Frame: every month in the course of 6 months ]
    Assess the improvement in C-peptide level after transplantation
  • Blood insulin level [ Time Frame: every month in the course of 6 months ]
    Assess the changes in blood insulin level after transplantation
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2018)
  • Fasting blood glucose [ Time Frame: every month in the course of 6 months ]
    Assess the changes in fasting blood glucose level after transplantation
  • C-peptide [ Time Frame: every month in the course of 6 months ]
    Assess the improvement in C-peptide level after transplantation
  • Hemoglobin A1c (HbA1c) level [ Time Frame: 1 month, 3 months and 6 months after transplantation ]
    Assess the changes in HbA1C level after transplantation
  • Insulin blood [ Time Frame: every month in the course of 6 months ]
    Assess the changes in Insulin blood level after transplantation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
Official Title  ICMJE A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: MSC and PRP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Phuong Le, MSc-MD (+84)902742732 drbphuong@gmail.com
Contact: Stem Cell Unit, Van Hanh General Hospital tebaogocvanhanh@gmail.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03484741
Other Study ID Numbers  ICMJE DIME 1001
DIME 1001 ( Other Identifier: Ministry of Health, Viet Nam )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 6 months after publication
Access Criteria: Type 1 Diabetes Mellitus
Responsible Party Van Hanh General Hospital
Study Sponsor  ICMJE Van Hanh General Hospital
Collaborators  ICMJE University of Science Ho Chi Minh City
Investigators  ICMJE
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
PRS Account Van Hanh General Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP