🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 1, Phase 2Ages 30 Years - 65 YearsAllPT. Prodia Stem Cell Indonesia
NCT07396155 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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. Inflammat

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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 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 Exclusion Criteria: * 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
💊

What it tests

  • Umbilical Cord Mesenchymal Stem Cells
📍

Where

1 site
Dr. Sardjito General Hospital
Yogyakarta, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy