Mesenchymal Stem Cells to Treat Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302599
• Other study ID #: CHIN-PLAGH-ST-003
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Mesenchymal Stem Cells
• Type 2 Diabetes

Intervention

Biological:
• Umbilical cord mesenchymal stem cells
Infusion treatment
• Controlled suspension liquid
Infusion treatment

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 weeks from baseline
Secondary	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%)	48 weeks from baseline
Secondary	Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D	Change of islet ß cell function and insulin resistance	48 weeks from baseline
Secondary	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.	48 weeks from baseline

External Links

•   Chinese PLA General Hospital Endocrinology medical characteristics