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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216849
Recruitment Status : Unknown
Verified June 2020 by Shanghai East Hospital.
Recruitment status was:  Recruiting
First Posted : January 3, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. UACR [ Time Frame: 48weeks after treatment ]
    urinary albumin creatinine ratio


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 48weeks after treatment ]
    HbA1c

  2. insulin/C peptide [ Time Frame: 48weeks after treatment ]
    serum level of insulin/C peptide

  3. insulin dosage [ Time Frame: 48weeks after treatment ]
    insulin dosage

  4. eGFR [ Time Frame: 48weeks after treatment ]
    estimated glomerular filtration rate


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216849


Contacts
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Contact: Congrong Wang, MD +86-021-38804518 wcr601@163.com
Contact: Zhongming Liu, MD +86-021-38804518 liu.zhongmin@tongji.edu.cn

Locations
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China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200124
Contact: Congrong Wang, MD    +86-021-38804518    wcr601@163.com   
Sponsors and Collaborators
Shanghai East Hospital
Chinese PLA General Hospital
Investigators
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Principal Investigator: Zhongming Liu, MD Shanghai East Hospital, Shanghai Tongji University
More Information
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04216849    
Other Study ID Numbers: DFSC-2019(CR)-06
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: June 2020

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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:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases