NCT07922889CompletedPhase 1/2
Mesenchymal Stem Cell Exosomes Alone or Combined With HUVEC Exosomes in Non-Dialysis Chronic Kidney Disease
Effect of Mesenchymal Stem Cell Exosomes in Inhibiting the Progression of Chronic Kidney Disease: A Randomized, Single-Blind, Placebo (Sham)-Controlled, Three-Arm Parallel Trial of Intravenous Human Wharton's Jelly Mesenchymal Stem Cell Exosomes Alone or Combined With Human Umbilical Vein Endothelial Cell Exosomes in Non-Dialysis CKD Stage 3-4
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether a single intravenous injection of exosomes derived from human Wharton's jelly mesenchymal stem cells (HWJ-MSC), given alone or together with exosomes derived from human umbilical vein endothelial cells (HUVEC), is safe and can help slow the progression of chronic kidney disease (CKD) in adults aged 18 to 65 years with stage 3-4 CKD who are not on dialysis. The main questions it aims to answer are: * Does exosome therapy, added to standard CKD care, help preserve kidney function (estimated glomerular filtration rate, eGFR) and reduce urine albumin (urine albumin-to-creatinine ratio, UACR) over 30 days? * Is a single intravenous exosome injection safe and well tolerated? Researchers compared three groups: standard therapy plus a saline (sham) injection, standard therapy plus HWJ-MSC exosomes, and standard therapy plus HWJ-MSC exosomes combined with HUVEC exosomes, to see whether exosome therapy, alone or in combination, improves kidney function and markers of systemic inflammation, fibrosis, oxidative stress, and endothelial dysfunction. Participants: * Received one intravenous injection on Day 1 and were observed closely for 1-2 hours afterwards * Continued their usual standard CKD treatment * Returned for a follow-up visit at Day 30 for blood and urine tests and a clinical examination
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 2 Nov 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Nurhasan Agung Prabowo
- Diseases
- Chronic kidney disease
- NCT number
- NCT07922889
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 34
- From 1 Jul 2026 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic immunosuppressive drugs within the past 3 months
Other illness
- History of malignancy (cancer) or active autoimmune disease
- Active chronic infection (HIV, hepatitis B, or hepatitis C)
Other
- Pregnancy or breastfeeding
Who the study is looking for
- Men and women aged 18-65 years
- Diagnosed with chronic kidney disease (CKD) stage 3 or 4, with estimated glomerular filtration rate (eGFR) of 15-59 mL/min/1.73 m\^2
- Have never undergone and are not currently undergoing kidney replacement therapy (hemodialysis or continuous ambulatory peritoneal dialysis/CAPD)
- Clinically stable on standard medical therapy for CKD for at least the past 3 months
- Willing to follow study procedures and to sign informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitas Sebelas Maret Hospital (RS UNS) | Sukoharjo | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.