Clinical trial NCT02302599: Mesenchymal Stem Cells to Treat Type 2 Diabetes
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Mesenchymal Stem Cells
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D
timeFrame: 48 weeks from baseline
Secondary outcomes:
measure: Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
timeFrame: 48 weeks from baseline
measure: Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
timeFrame: 48 weeks from baseline
measure: safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D
timeFrame: 48 weeks from baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: weidong HAN
role: STUDY_DIRECTOR
affiliation: Chinese PLA General Hospital
name: yiming MU
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.