Mesenchymal Stem Cells to Treat Type 2 Diabetes

NCT02302599 | Completed Phase 2 DMC

• 1 other identifier: CHIN-PLAGH-ST-003
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes; Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D

  48 weeks from baseline

• Other efficacy parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D

  48 weeks from baseline

• safety parameter of umbilical-cord mesenchymal stem cells in Chinese adults with T2D

  48 weeks from baseline

Study Arms (2)

Umbilical cord mesenchymal stem cells

EXPERIMENTAL

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

Controlled suspension liquid

EXPERIMENTAL

Patients receive Controlled suspension liquid

Biological: Controlled suspension liquid

Interventions

Umbilical cord mesenchymal stem cells BIOLOGICAL

Infusion treatment

Umbilical cord mesenchymal stem cells

Controlled suspension liquid BIOLOGICAL

Infusion treatment

Controlled suspension liquid

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤ 65 years;
• Duration of type 2 diabetes ≤20 years;
• kg/m2 ≤ BMI ≤40.0 kg/m2;
• 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;
• % ≤ HbA1c ≤ 12.0%;
• Fasting C-peptide ≥ 1ng/ml;
• Willingness to participate in the trial.

You may not qualify if:

• 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;
• Severe concurrent illness limiting life expectancy, inadequate understanding of the study protocol, drug abuse, pregnant willing and allergic constitution.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (4)

• 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.

  PMID: 23770360 BACKGROUND

• 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.

  PMID: 16681924 BACKGROUND

• 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.

  PMID: 22618776 BACKGROUND

• 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.

  PMID: 35505375 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• weidong HAN

  Chinese PLA General Hospital

  STUDY DIRECTOR

• yiming MU

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: UC-MSCs (1.5×106/kg) or the same volume of placebo (suspension liquid without UC-MSCs)

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 27, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

CN (1)