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

Phase 1

• Conditions: Type 2 Diabetes With Renal Manifestations

• Registration Number: NCT04216849
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-03
• Status Verified: 2020-06
• Study Start: 2020-07-01
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17
• Primary Completion: 2022-02-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
UACR	48weeks after treatment	urinary albumin creatinine ratio

Secondary Outcome Measures

Name	Time	Method
HbA1c	48weeks after treatment	HbA1c
eGFR	48weeks after treatment	estimated glomerular filtration rate
insulin/C peptide	48weeks after treatment	serum level of insulin/C peptide
insulin dosage	48weeks after treatment	insulin dosage

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China