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Mesenchymal Stem Cells to Treat Type 2 Diabetes (UC-MSCs)

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ClinicalTrials.gov Identifier: NCT02302599
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Yiming Mu, Chinese PLA General Hospital

Study Description
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Brief Summary:
Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mesenchymal Stem Cells Biological: Umbilical cord mesenchymal stem cells Biological: Controlled suspension liquid Phase 2

Detailed Description:
Umbilical cord mesenchymal stem cells can improve insulin resistance of the target tissues, reduce the islet progressive damage, ease or regenerate of the islet beta cells and improve hyperglycemic state of diabetes by secreting a variety of cytokines. It can induce damaged alpha cells differentiate into beta cells in the islet transformation to realize the islet beta cells in situ regeneration by improving microenvironment of islet beta cells. Umbilical cord mesenchymal stem cells also have immunosuppressive effect, it can promote islet cell repair and regeneration by the inhibition of T cell mediated immune response to beta cells.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All investigators and participants were masked to treatment allocation. The independent data monitoring committee and the statisticians supporting the committee's activities were the only people with access to unblinded data.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Umbilical-cord Mesenchymal Stem Cells in Chinese Adults With Type 2 Diabetes: a Single Center, Double-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Umbilical cord mesenchymal stem cells
Patients receive Umbilical cord mesenchymal stem cells intravenous infusion for three times with an interval of 4 weeks in the absence of disease progression or unacceptable toxicity
 Biological: Umbilical cord mesenchymal stem cells
Infusion treatment
Experimental: Controlled suspension liquid
Patients receive Controlled suspension liquid
 Biological: Controlled suspension liquid
Infusion treatment


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D [ Time Frame: 48 weeks from baseline ]
    proportion of patients with HbA1c <7.0% and daily insulin reduction ≥50% from baseline to 48 weeks


Secondary Outcome Measures :
  1. Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D [ Time Frame: 48 weeks from baseline ]
    Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (<7.0%)

  2. Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D [ Time Frame: 48 weeks from baseline ]
    Change of islet β cell function and insulin resistance

  3. safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D [ Time Frame: 48 weeks from baseline ]
    Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20 ≤ age ≤ 65 years;
  2. Duration of type 2 diabetes ≤20 years;
  3. 24.0 kg/m2 ≤ BMI ≤40.0 kg/m2;
  4. Stable exogenous insulin dose between 0.5-1.0 U/Kg/Day with or without oral hypoglycemic agents (Dipeptidyl peptidase-4 (DPP-4) inhibitor, Glucagon like peptide 1 receptor (GLP-1R) agonist and Sodium-glucose co-transporter 2 (SGLT-2) inhibitor excluded) for at least 3 months;
  5. 7.0% ≤ HbA1c ≤ 12.0%;
  6. Fasting C-peptide ≥ 1ng/ml;
  7. Willingness to participate in the trial.

Exclusion Criteria:

  1. Patients with ketonuria, tumor, serum creatinine level more than 175μmol/L, myocardial infarction in the previous year, current angina or heart failure, more than one major vascular event, retinopathy requiring laser treatment, malignant hypertension, uncorrected endocrine disorder, occupations precluding insulin therapy;
  2. Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.
Contacts and Locations
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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): NCT02302599


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100039
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Director: weidong HAN Chinese PLA General Hospital
Principal Investigator: yiming MU Chinese PLA General Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yiming Mu, Director, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02302599    
Other Study ID Numbers: CHIN-PLAGH-ST-003
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases