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

Recruiting Phase 1 Phase 2 Interventional Study
Diabetic Nephropathy Type 2
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
30 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
PT. Prodia Stem Cell Indonesia · Industry
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About This Trial
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?…
Trial Locations
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Eligibility Criteria
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 II…
Contacts

Metalia Puspitasari, MD

+628116110283

puspitasarimetalia@gmail.com

CONTACT