Back to resultsMesenchymal Stem Cells to Treat Type 2 Diabetes (UC-MSCs)
Primary Purpose
Type 2 Diabetes, Mesenchymal Stem Cells
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Umbilical cord mesenchymal stem cells
Controlled suspension liquid
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Umbilical cord mesenchymal stem cells
Controlled suspension liquid
Arm Description
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
Patients receive Controlled suspension liquid
Outcomes
Primary Outcome Measures
The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D
proportion of patients with HbA1c <7.0% and daily insulin reduction ≥50% from baseline to 48 weeks
Secondary Outcome Measures
Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (<7.0%)
Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Change of islet β cell function and insulin resistance
safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function.
Full Information
NCT ID
NCT02302599
First Posted
November 12, 2014
Last Updated
February 1, 2021
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02302599
Brief Title
Mesenchymal Stem Cells to Treat Type 2 Diabetes
Acronym
UC-MSCs
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Mesenchymal Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm Description
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
Arm Title
Controlled suspension liquid
Arm Type
Experimental
Arm Description
Patients receive Controlled suspension liquid
Intervention Type
Biological
Intervention Name(s)
Umbilical cord mesenchymal stem cells
Intervention Description
Infusion treatment
Intervention Type
Biological
Intervention Name(s)
Controlled suspension liquid
Intervention Description
Infusion treatment
Primary Outcome Measure Information:
Title
The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D
Description
proportion of patients with HbA1c <7.0% and daily insulin reduction ≥50% from baseline to 48 weeks
Time Frame
48 weeks from baseline
Secondary Outcome Measure Information:
Title
Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Description
Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (<7.0%)
Time Frame
48 weeks from baseline
Title
Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Description
Change of islet β cell function and insulin resistance
Time Frame
48 weeks from baseline
Title
safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
Description
Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function.
Time Frame
48 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
weidong HAN
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
yiming MU
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23770360
Citation
Hao H, Liu J, Shen J, Zhao Y, Liu H, Hou Q, Tong C, Ti D, Dong L, Cheng Y, Mu Y, Liu J, Fu X, Han W. Multiple intravenous infusions of bone marrow mesenchymal stem cells reverse hyperglycemia in experimental type 2 diabetes rats. Biochem Biophys Res Commun. 2013 Jul 5;436(3):418-23. doi: 10.1016/j.bbrc.2013.05.117. Epub 2013 Jun 11.
Results Reference
background
PubMed Identifier
16681924
Citation
Wang XL, Lu JM, Pan CY, Mu YM, Dou JT, Ba JM. [Characteristics of the daily blood glucose profiles of impaired glucose tolerance and type 2 diabetes mellitus subjects by continuous glucose monitoring system]. Zhonghua Yi Xue Za Zhi. 2006 Mar 14;86(10):674-7. Chinese.
Results Reference
background
PubMed Identifier
22618776
Citation
Si Y, Zhao Y, Hao H, Liu J, Guo Y, Mu Y, Shen J, Cheng Y, Fu X, Han W. Infusion of mesenchymal stem cells ameliorates hyperglycemia in type 2 diabetic rats: identification of a novel role in improving insulin sensitivity. Diabetes. 2012 Jun;61(6):1616-25. doi: 10.2337/db11-1141.
Results Reference
background
PubMed Identifier
35505375
Citation
Zang L, Li Y, Hao H, Liu J, Cheng Y, Li B, Yin Y, Zhang Q, Gao F, Wang H, Gu S, Li J, Lin F, Zhu Y, Tian G, Chen Y, Gu W, Du J, Chen K, Guo Q, Yang G, Pei Y, Yan W, Wang X, Meng J, Zhang S, Ba J, Lyu Z, Dou J, Han W, Mu Y. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial. Stem Cell Res Ther. 2022 May 3;13(1):180. doi: 10.1186/s13287-022-02848-6.
Results Reference
derived
Learn more about this trial
Mesenchymal Stem Cells to Treat Type 2 Diabetes
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