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Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Diabetic Nephropathy

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Study Aim

This study aims to evaluate the safety of using allogeneic umbilical cord mesenchymal stem cell therapy as a treatment for diabetic nephropathy, by monitoring the incidence of adverse events and serious adverse events in participants.

What is being tested

Umbilical Cord Mesenchymal Stem Cells

Biological
Who is being recruted

Urogenital Diseases+7

+ Diabetes Mellitus

+ Diabetic Nephropathies

From 30 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: July 2026
See protocol details

Summary

Principal SponsorPT. Prodia Stem Cell Indonesia
Study ContactMetalia Puspitasari, MD
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on diabetic nephropathy, a common complication of diabetes that can lead to severe kidney disease. Despite current treatments, many patients still experience a decline in kidney function. This study explores a new approach using mesenchymal stem cells (MSCs), specifically from umbilical cord tissue, due to their anti-inflammatory and regenerative potential shown in early studies. The goal is to assess the safety and potential benefits of this therapy for individuals with diabetic nephropathy, aiming to improve current treatment options and slow down the disease progression. Participants in this trial will receive the treatment through an intra-renal injection. The study will monitor any adverse events or reactions to the therapy, both locally and throughout the body, to evaluate its safety. The primary outcome is to measure changes in kidney function and inflammatory markers over time, providing insights into the effects of MSC therapy on diabetic nephropathy. This research offers a significant step towards developing new interventions for chronic kidney disease, contributing valuable data to the emerging field of regenerative nephrology.

Official TitleSafety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
Principal SponsorPT. Prodia Stem Cell Indonesia
Study ContactMetalia Puspitasari, MD
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes MellitusDiabetic NephropathiesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesDiabetes ComplicationsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
Diagnosed with Type 2 Diabetes Mellitus (T2DM)

Aged between 40 and 65 years

Controlled diabetes, defined as HbA1c <10.0% during screening

Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample)

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7 exclusion criteria prevent from participating
Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone

Positive pregnancy test or currently breastfeeding (for women of reproductive age)

Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)

Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dr. Sardjito General Hospital

Yogyakarta, IndonesiaOpen Dr. Sardjito General Hospital in Google Maps
Recruiting
One Study Center
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