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

February 1, 2021 updated by: Yiming Mu, Chinese PLA General Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%)
48 weeks from baseline
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
48 weeks from baseline
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.
48 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Director: weidong HAN, Chinese PLA General Hospital
  • Principal Investigator: yiming MU, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIN-PLAGH-ST-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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