Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedDecember 17, 2020
June 1, 2020
1.6 years
December 17, 2019
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UACR
urinary albumin creatinine ratio
48weeks after treatment
Secondary Outcomes (4)
HbA1c
48weeks after treatment
insulin/C peptide
48weeks after treatment
insulin dosage
48weeks after treatment
eGFR
48weeks after treatment
Study Arms (2)
experimental group
EXPERIMENTALThe 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.
control group
PLACEBO COMPARATORThe control group will be given the same dose of saline containing human albumin.
Interventions
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
Saline solution containing human serum albumin will be infused to the control group
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Diabetes duration≤20 years
- kg/m\^2 ≤ BMI\< 30 kg/m\^2
- %≤HbA1C≤10%
- UACR≥30mg/gCr
- eGFR ≥45/milliliter/1.73m\^2
You may not qualify if:
- Type 1 diabetes mellitus
- tumor history
- Other causes of chronic kidney disease
- Abnormal liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai East Hospitallead
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200124, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongming Liu, MD
Shanghai East Hospital, Shanghai Tongji University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2019
First Posted
January 3, 2020
Study Start
July 1, 2020
Primary Completion
February 1, 2022
Study Completion
July 1, 2022
Last Updated
December 17, 2020
Record last verified: 2020-06