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Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

NCT04125329 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-04-21

No results posted yet for this study

Summary

This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month .Endpoints:Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks).Secondary endpoint indicators:Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.

Conditions

  • Mesenchymal Stem Cells
  • Diabetic Nephropathy

Interventions

DRUG

Human umbilical cord mesenchymal stem cells

Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times

Sponsors & Collaborators

  • Yan'an Affiliated Hospital of Kunming Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2024-09-01
Completion
2024-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04125329 on ClinicalTrials.gov