NCT07396155

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

Recruiting now Phase 1/Phase 2 Last updated 3 February 2026

What this trial tests

Phase 1/Phase 2 trial testing Umbilical Cord Mesenchymal Stem Cells in Diabetic Nephropathy Type 2 in 10 participants. Currently enrolling.

Timeline

1 July 2026

Primary endpoint
1 July 2027

1 October 2027

Quick facts

Lead sponsor	PT. Prodia Stem Cell Indonesia
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 July 2026
Primary completion	1 July 2027
Estimated completion	1 October 2027
Sites	1 location across Indonesia

Drugs / interventions tested

• Umbilical Cord Mesenchymal Stem Cells

Conditions studied

• Diabetic Nephropathy Type 2 — all drugs for Diabetic Nephropathy Type 2 →

Sponsor

PT. Prodia Stem Cell Indonesia — full company profile →

Who can join

Adults 30 to 65, any sex, with Diabetic Nephropathy Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial.