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Completed

NCT Number: NCT02302599

Mesenchymal Stem Cells to Treat Type 2 Diabetes

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 ≤ age ≤ 65 years;
  • Duration of type 2 diabetes ≤20 years;
  • 24.0 kg/m2 ≤ BMI ≤40.0 kg/m2;
  • 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;
  • 7.0% ≤ HbA1c ≤ 12.0%;
  • Fasting C-peptide ≥ 1ng/ml;
  • Willingness to participate in the trial.

Exclusion criteria

  • 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;
  • Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

Infusion treatment

Controlled suspension liquid

Biological

Infusion treatment

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study 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

Acronym: UC-MSCs

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2014
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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