Mesenchymal Stem Cells to Treat Type 2 Diabetes

Phase 2

Completed

• Conditions: Mesenchymal Stem Cells; Type 2 Diabetes
• Interventions: Biological: Umbilical cord mesenchymal stem cells; Biological: Controlled suspension liquid

• Registration Number: NCT02302599
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord mesenchymal stem cells	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
Controlled suspension liquid	Controlled suspension liquid	Patients receive Controlled suspension liquid

Primary Outcome Measures

Name	Time	Method
The efficacy of umbilical cord mesenchymal stem cells in Chinese adults with T2D	48 weeks from baseline	proportion of patients with HbA1c \<7.0% and daily insulin reduction ≥50% from baseline to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D	48 weeks from baseline	Change of islet β cell function and insulin resistance
safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D	48 weeks from baseline	Fever, pruritus, nausea and vomiting, anaphylactic shock, phlebitis，tumor formation, infection, impaired liver and kidney function.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China