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

NCT07396155 | Recruiting Phase 1

• 1 other identifier: CT/DN/01/2025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?
2. 2.Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?
3. 3.Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)
4. 4.Inflammatory markers (TNF-α, IL-10)
5. 5.Safety outcomes including early and late adverse events

Conditions

Diabetic Nephropathy Type 2

Keywords

Umbilical Cord Mesenchymal Stem Cell; Diabetic Nephropathy; Kidney Disease; Intra-renal Injection; TNF-alpha; IL-10; Glomerular Filtration Rate; eGFR; Regenerative Medicine; Mesenchymal Stem Cells; UC-MSC

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events and Serious Adverse Events

  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 Outcomes (3)

• Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline and at 1, 3, 6, 9, and 12 months after treatment

• Change in Serum Creatinine

  Baseline and at 1, 3, 6, 9, and 12 months after treatment

• Change in Urine Albumin-to-Creatinine Ratio (UACR)

  Baseline and at 1, 3, 6, 9, and 12 months after treatment

Other Outcomes (2)

• Change in Serum TNF-α Levels

  Baseline and at 1, 3, 6, 9, and 12 months after treatment

• Change in Serum IL-10 Levels

  Baseline and at 1, 3, 6, 9, and 12 months after treatment

Study Arms (1)

UC-MSC treatment group

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.

Biological: Umbilical Cord Mesenchymal Stem Cells

Interventions

Umbilical Cord Mesenchymal Stem Cells BIOLOGICAL

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.

UC-MSC treatment group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead
• Dr. Sardjito General Hospital, Yogyakarta, Indonesia: collaborator

Study Sites (1)

Dr. Sardjito General Hospital

Yogyakarta, 55284, Indonesia

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Metalia Puspitasari, MD

CONTACT

+628116110283; puspitasarimetalia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: February 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-06

Locations

ID (1)