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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Indonesia
Dr. Sardjito General Hospital
RECRUITING
Yogyakarta
Contact Information
Primary
Metalia Puspitasari, MD
puspitasarimetalia@gmail.com
+628116110283
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-10
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Dr. Sardjito General Hospital, Yogyakarta, Indonesia
Leads: PT. Prodia Stem Cell Indonesia

This content was sourced from clinicaltrials.gov