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.
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