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

• Sponsor: Shanghai East Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04216849
• Collaborator: Chinese PLA General Hospital (Other)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes With Renal Manifestations	Biological: human umbilical cord mesenchymal stem cells; Other: saline	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. UACR [48weeks after treatment]

   urinary albumin creatinine ratio

Secondary Outcome Measures

1. HbA1c [48weeks after treatment]

   HbA1c

2. insulin/C peptide [48weeks after treatment]

   serum level of insulin/C peptide

3. insulin dosage [48weeks after treatment]

   insulin dosage

4. eGFR [48weeks after treatment]

   estimated glomerular filtration rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hospital	Shanghai	Shanghai	China	200124

Sponsors and Collaborators

• Shanghai East Hospital
• Chinese PLA General Hospital

Investigators

• Principal Investigator: Zhongming Liu, MD, Shanghai East Hospital, Shanghai Tongji University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai East Hospital
• ClinicalTrials.gov Identifier: NCT04216849
• Other Study ID Numbers: DFSC-2019(CR)-06
• First Posted: Jan 3, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai East Hospital: human umbilical cord mesenchymal stem cells; type 2 diabetic nephropathy
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies

Study Results

No Results Posted as of Dec 17, 2020