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Trial record 19 of 2193 for:    stem cells | Recruiting, Active, not recruiting, Enrolling by invitation Studies

Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes (ASD2)

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ClinicalTrials.gov Identifier: NCT03343782
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell Phase 2

Detailed Description:
Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus at Vinmec International Hospital, Hanoi, Vietnam

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 30 patients were randomly assigned into 2 groups for injection (intravenous injection or dorsal pancreatic artery infusion).
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes: An Open-label, Randomized Controlled Clinical Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intravenous injection
Intervention: 15 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells by using intravenous injection and undergoing 2 treatment with 6 months interval
Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell
Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure

Experimental: Dorsal pancreatic artery infusion
Intervention: 15 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells by using the dorsal pancreatic artery and undergoing 2 treatment with 6 months interval
Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell
Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure




Primary Outcome Measures :
  1. Insulin dose [ Time Frame: up to the 12-month period following treatment ]
    Reduction of insulin dose requirement by ≥50% in both groups

  2. Adverse events [ Time Frame: up to the 12-month period following treatment ]
    Number of adverse events in both groups


Secondary Outcome Measures :
  1. Fasting glucose [ Time Frame: up to the 12-month period following treatment ]
    Change from baseline in fasting glucose over time between two groups

  2. Hemoglobin A1c (HbA1c) level [ Time Frame: up to the 12-month period following treatment ]
    Improvement of HbA1c level as compared to baseline between two groups



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between age 30 and 70 years.
  • Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
  • Type 2 diabetes duration 5 years or more.
  • Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
  • Who signed the informed consent form.

Exclusion Criteria:

  • Type 1 diabetes.
  • Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
  • According to the medical doctor's judgement, may endanger the safety of the subjects

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): NCT03343782


Locations
Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 10000
Contact: Liem T Nguyen, MD, PhD    (+84 4) 3 974 3556 ext 1420    v.liemnt@vinmec.com   
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology

Publications of Results:
Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03343782     History of Changes
Other Study ID Numbers: VinmecRISCGT70
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Diabetes
BM mesenchymal stem cell

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases