Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes With Renal Manifestations
• Intervention / Treatment: Biological: human umbilical cord mesenchymal stem cells; Other: saline

Detailed Description

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Congrong Wang, MD; Phone Number: +86-021-38804518; Email: wcr601@163.com
• Study Contact Backup: Name: Zhongming Liu, MD; Phone Number: +86-021-38804518; Email: liu.zhongmin@tongji.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200124
      • Recruiting
      • Shanghai East Hospital
      • Contact: Congrong Wang, MD; Phone Number: +86-021-38804518; Email: wcr601@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (in brief):

• Type 2 diabetes mellitus
• Diabetes duration≤20 years
• 18.5kg/m^2 ≤ BMI< 30 kg/m^2
• 7.5%≤HbA1C≤10%
• UACR≥30mg/gCr
• eGFR ≥45/milliliter/1.73m^2

Exclusion Criteria (in brief):

• Type 1 diabetes mellitus
• tumor history
• Other causes of chronic kidney disease
• Abnormal liver function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week.	Biological: human umbilical cord mesenchymal stem cells; human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
Placebo Comparator: control group; The control group will be given the same dose of saline containing human albumin.	Other: saline; Saline solution containing human serum albumin will be infused to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UACR	urinary albumin creatinine ratio	48weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c	48weeks after treatment
insulin/C peptide	serum level of insulin/C peptide	48weeks after treatment
insulin dosage	insulin dosage	48weeks after treatment
eGFR	estimated glomerular filtration rate	48weeks after treatment

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Chinese PLA General Hospital
• Investigators: Principal Investigator: Zhongming Liu, MD, Shanghai East Hospital, Shanghai Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: human umbilical cord mesenchymal stem cells; type 2 diabetic nephropathy
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: DFSC-2019(CR)-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No