Type 2 Diabetes Clinical Trial
— UC-MSCsOfficial 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
Verified date | February 2021 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Umbilical cord mesenchymal stem cells indicate the therapeutic effects and safety on type 2 diabetes by characteristics of secretion and immune Immunomodulation.
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
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
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 |
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