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

Type 2 Diabetes With Renal Manifestations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04216849
• Other study ID #: DFSC-2019(CR)-06
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2020
• Source: Shanghai East Hospital
• Contact: Congrong Wang, MD
• Phone: +86-021-38804518
• Email: wcr601[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetes With Renal Manifestations

Intervention

Biological:
• human umbilical cord mesenchymal stem cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group

Other:
• saline
Saline solution containing human serum albumin will be infused to the control group

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai East Hospital	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UACR	urinary albumin creatinine ratio	48weeks after treatment
Secondary	HbA1c	HbA1c	48weeks after treatment
Secondary	insulin/C peptide	serum level of insulin/C peptide	48weeks after treatment
Secondary	insulin dosage	insulin dosage	48weeks after treatment
Secondary	eGFR	estimated glomerular filtration rate	48weeks after treatment