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Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial

NCT07396155 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-09

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are:

1. Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?
2. Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?

This is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells/kg body weight.

Participants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of:

1. Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)
2. Inflammatory markers (TNF-α, IL-10)
3. Safety outcomes including early and late adverse events

The results will be compared to baseline measurements to assess changes after the intervention.

If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\].

Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Conditions

  • Diabetic Nephropathy Type 2

Interventions

BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cells

This intervention consists of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) administered under imaging guidance. The dose administered is 1 × 10⁶ cells per kilogram of body weight.

Sponsors & Collaborators

  • Dr. Sardjito General Hospital, Yogyakarta, Indonesia

    collaborator UNKNOWN

  • PT. Prodia Stem Cell Indonesia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-31
Completion
2027-10-31

Countries

  • Indonesia

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 NCT07396155 on ClinicalTrials.gov