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

February 3, 2026 updated by: PT. Prodia Stem Cell Indonesia

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].

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diabetic nephropathy (DN) is one of the most common microvascular complications of diabetes mellitus and a leading cause of end-stage renal disease worldwide. Despite current standard therapies, many patients continue to experience progressive decline in renal function. As inflammation and immune dysregulation are increasingly recognized as contributors to DN pathogenesis, novel therapeutic strategies targeting these mechanisms are being explored.

Mesenchymal stem cells (MSCs), particularly those derived from umbilical cord tissue, have shown promising anti-inflammatory and regenerative effects in preclinical studies of kidney disease. Their immunomodulatory properties, low immunogenicity, and ease of collection make them a compelling option for cell-based therapies.

This clinical trial aims to evaluate the safety and potential therapeutic benefit of allogeneic umbilical cord-derived MSCs administered via intra-renal injection in individuals with diabetic nephropathy. The study is designed to provide early human data on the feasibility of using UC-MSCs as an adjunctive therapy in DN management. By assessing changes in renal function and inflammatory biomarkers over time, the trial seeks to explore the biological impact of UC-MSC therapy in this population.

This research represents an important step toward developing cell-based interventions for chronic kidney disease, particularly in settings where conventional treatments are insufficient. The findings are expected to contribute valuable data to the growing field of regenerative nephrology.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Yogyakarta, Indonesia, 55284
        • Recruiting
        • Dr. Sardjito General Hospital
        • Contact:
        • Principal Investigator:
          • Metalia Puspitasari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with Type 2 Diabetes Mellitus (T2DM)
  • Aged between 40 and 65 years
  • Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL/min/1.73 m² (using CKD-EPI formula)
  • Renal biopsy showing diabetic nephropathy type IIa-IV
  • Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample)
  • Controlled diabetes, defined as HbA1c <10.0% during screening
  • Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg
  • On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening
  • Willing to provide written informed consent and comply with all study procedures until completion

Exclusion Criteria:

  • Active malignancy or history of cancer
  • Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)
  • Hemoglobin <8 g/dL or platelet count <100,000/µL
  • Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months
  • Positive pregnancy test or currently breastfeeding (for women of reproductive age)
  • Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone
  • History of participation in other stem cell research or therapy studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UC-MSC treatment group
Participants will receive a single intra-renal injection of UC-MSCs (1 × 10⁶ cells/kg BW), followed by a 12-month monitoring period for safety and renal function outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events and Serious Adverse Events
Time Frame: From baseline up to 12 months post-injection
Safety is assessed by recording the number and percentage of participants experiencing any adverse events (AEs), including both local and systemic reactions.
From baseline up to 12 months post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Calculated using the CKD-EPI 2021 formula
Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Serum Creatinine
Time Frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Measured in mg/dL. Collected via venous blood samples
Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Measured in mg/g from morning spot urine samples
Baseline and at 1, 3, 6, 9, and 12 months after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum TNF-α Levels
Time Frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Tumor necrosis factor-alpha (TNF-α) is measured in patient serum using ELISA as a marker of systemic inflammation. The change in TNF-α concentration from baseline over 12 months will be analyzed to evaluate the immunomodulatory effect of UC-MSC therapy.
Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Serum IL-10 Levels
Time Frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Interleukin-10 (IL-10) is measured in patient serum using ELISA as an anti-inflammatory cytokine. This outcome assesses whether UC-MSC treatment modulates IL-10 levels over a 12-month follow-up period.
Baseline and at 1, 3, 6, 9, and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Collaborators

Dr. Sardjito General Hospital, Yogyakarta, Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

July 7, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/DN/01/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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