UC-MSCs: Mesenchymal Stem Cells to Treat Type 2 Diabetes

• Sponsor: Chinese PLA General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02302599
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Arms: 2
• Actual Duration (Months): 95
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Mesenchymal Stem Cells	Biological: Umbilical cord mesenchymal stem cells; Biological: Controlled suspension liquid	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: Umbilical cord mesenchymal stem cells; Infusion treatment
Experimental: Controlled suspension liquid Patients receive Controlled suspension liquid	Biological: Controlled suspension liquid; Infusion treatment

Outcome Measures

Primary Outcome Measures

1. 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

1. Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D [48 weeks from baseline]

   Changes of insulin requirement, HbA1c and proportion of patients reaching the HbA1c target (<7.0%)

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100039

Sponsors and Collaborators

• Chinese PLA General Hospital

Investigators

• Study Director: weidong HAN, Chinese PLA General Hospital
• Principal Investigator: yiming MU, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Chinese PLA General Hospital Endocrinology medical characteristics

Publications

• 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.
• 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.
• 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.

• Responsible Party: Yiming Mu, Director, Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT02302599
• Other Study ID Numbers: CHIN-PLAGH-ST-003
• First Posted: Nov 27, 2014
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 3, 2021