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

Tongji University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Type 2 Diabetes With Renal Manifestations

Treatments: Biological: human umbilical cord mesenchymal stem cells; Other: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04216849

DFSC-2019(CR)-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

Description:

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.

Treatment:

Biological: human umbilical cord mesenchymal stem cells

control group

Placebo Comparator group

Description:

The control group will be given the same dose of saline containing human albumin.

Treatment:

Other: saline