A Phase 1/2 interventional study of Human Wharton's jelly mesenchymal stem cell (HWJ-MSC) exosomes and Human umbilical vein endothelial cell (HUVEC) exosomes in Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4 and Chronic Kidney Disease, sponsored by Nurhasan Agung Prabowo. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Nurhasan Agung Prabowo · Phase 1/2, Interventional, and Treatment
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:
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:
BACKGROUND
Chronic kidney disease (CKD) is a major and growing health problem in Indonesia. National basic health research data (Riskesdas) showed that CKD prevalence rose from 2.0 per mille in 2013 to 3.8 per mille in 2018, and hemodialysis is consistently among the largest catastrophic expenditures of the National Health Insurance (JKN) program. CKD progression is driven by persistent inflammation, oxidative stress, endothelial dysfunction, TGF-beta1-mediated interstitial fibrosis, and loss of peritubular capillaries. Exosomes from human Wharton's jelly mesenchymal stem cells (HWJ-MSC) carry microRNAs such as miR-146a (suppressing NF-kB pro-inflammatory signaling) and miR-let-7c (suppressing TGF-beta1 receptor signaling) with anti-inflammatory and anti-fibrotic effects, while exosomes from human umbilical vein endothelial cells (HUVEC) stimulate angiogenesis and may repair ischemic renal microvasculature. This early-phase trial builds on preclinical in vivo work in a CKD mouse model.
STUDY DESIGN
Single-center, randomized, single-blind (participant-masked), placebo (sham)-controlled, three-arm parallel-group trial conducted at Universitas Sebelas Maret Hospital, Sukoharjo, Indonesia. Non-dialysis patients with CKD stage 3-4 were enrolled by consecutive sampling from the nephrology-hypertension outpatient clinic and randomly allocated 1:1:1 using a centrally managed computer-generated randomization list (Microsoft Excel). Participants were not told which treatment they received, to minimize bias in adverse event reporting. The planned sample size was 60 participants; 34 participants were enrolled.
INVESTIGATIONAL PRODUCTS
Both exosome products were manufactured under Good Manufacturing Practice (GMP) by PT Dermama Bioteknologi Laboratorium (industry partner):
Release criteria included particle size 30-150 nm, CD63/CD9 surface marker positivity, sterility testing, and endotoxin below 32 EU/mL. Products were delivered in cold-chain packaging.
TREATMENT GROUPS
All participants continued standard medical therapy for CKD according to KDIGO guidelines: blood pressure control and antiproteinuric therapy (ACE inhibitor or ARB), fluid management (fluid restriction and/or diuretics such as furosemide), and supportive therapy (anemia correction, phosphate binders, low-protein diet).
STUDY PROCEDURES
Serum/plasma biomarkers (hs-CRP, TGF-beta1, MDA, ADMA) were measured by ELISA at the Department of Biomedicine, Faculty of Medicine, Universitas Sebelas Maret.
SAMPLE SIZE
The planned sample size was based on a comparison of two means with two-sided alpha 0.05, power 80%, an assumed standard deviation of 3.5 mL/min/1.73 m\^2 for change in eGFR, and a minimal clinically important difference of 3.5 mL/min/1.73 m\^2, giving a minimum of 15.68 participants per group, rounded up to 20 per group (60 in total) to allow for dropout.
STATISTICAL ANALYSIS
Analyses follow the intention-to-treat (ITT) principle using SPSS. Baseline characteristics are compared using the chi-square test (categorical data) and one-way ANOVA or Kruskal-Wallis test (numerical data). Changes (delta) from baseline to Day 30 in renal function parameters and biomarkers are compared among the three groups using one-way ANOVA (normal distribution) or the Kruskal-Wallis test (non-normal distribution), followed by post-hoc tests. Statistical significance is set at p \< 0.05.
FUNDING
Funded by the Riset Kolaborasi Indonesia (RKI) Scheme B 2026 grant (proposal registration no. 00070574056182026), with Universitas Sebelas Maret as host institution and PT Dermama Bioteknologi Laboratorium as industry partner.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 34 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Nurhasan Agung Prabowo is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard medical therapy for CKD according to KDIGO guidelines plus a single slow intravenous bolus/drip of 0.9% NaCl (1-2 mL) on Day 1.
Drug: Placebo (0.9% sodium chloride)
Standard medical therapy for CKD according to KDIGO guidelines plus a single slow intravenous bolus/drip of 1 vial (1 mL; 7.9 x 10\^7 particles) of HWJ-MSC exosomes on Day 1.
Biological: Human Wharton's jelly mesenchymal stem cell (HWJ-MSC) exosomes
Standard medical therapy for CKD according to KDIGO guidelines plus a single slow intravenous bolus/drip of 1 vial HWJ-MSC exosomes (7.9 x 10\^7 particles) and 1 vial HUVEC exosomes (5.7 x 10\^5 particles), total volume 2 mL, on Day 1.
Biological: Human Wharton's jelly mesenchymal stem cell (HWJ-MSC) exosomes · Biological: Human umbilical vein endothelial cell (HUVEC) exosomes
Cell-free GMP-grade exosome product manufactured by PT Dermama Bioteknologi Laboratorium; 1 mL vial containing 7.9 x 10\^7 particles/mL. Single dose given as a slow intravenous bolus/drip on Day 1. Intended to exert anti-inflammatory and immunomodulatory effects and promote regeneration of renal parenchyma.
Also known as: HWJ-MSC-derived extracellular vesicles
Cell-free GMP-grade exosome product manufactured by PT Dermama Bioteknologi Laboratorium; 1 mL vial containing 5.7 x 10\^5 particles/mL. Single dose given intravenously together with HWJ-MSC exosomes on Day 1. Intended to stimulate angiogenesis and repair renal capillary microvasculature damaged by chronic ischemia.
Also known as: HUVEC-derived extracellular vesicles
0.9% NaCl 1-2 mL given as a single slow intravenous bolus/drip on Day 1 as a sham injection.
Also known as: Normal saline
Change in estimated glomerular filtration rate (eGFR)
eGFR (mL/min/1.73 m\^2) calculated with the CKD-EPI 2021 equation from serum creatinine, as the main indicator of renal excretory function. The change from baseline to Day 30 is compared among the three groups.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in serum creatinine
Serum creatinine (mg/dL) as a measure of retention of metabolic waste products.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in blood urea (BUN)
Serum urea / blood urea nitrogen (mg/dL) as a measure of retention of metabolic waste products.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in urine albumin-to-creatinine ratio (UACR)
UACR (mg/g) measured in a random (spot) urine sample, as an indicator of glomerular/podocyte structural damage and albumin leakage.
Time frame: Baseline (Day 0) and Day 30 after injection
Number of participants with adverse events
Safety and tolerability of intravenous exosome administration: adverse events following injection, including infusion reactions and anaphylaxis during the 1-2 hour post-injection observation period, and any adverse events reported through the Day 30 visit.
Time frame: From injection (Day 1) through Day 30
Change in high-sensitivity C-reactive protein (hs-CRP)
Serum/plasma hs-CRP concentration (pg/mL) measured by ELISA, as a marker of persistent systemic chronic inflammation in CKD.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in interleukin-6 (IL-6)
Serum IL-6 measured by ELISA, as the main pro-inflammatory cytokine to evaluate the systemic immunomodulatory effect of the exosomes.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in transforming growth factor-beta1 (TGF-beta1)
Serum/plasma TGF-beta1 concentration (ng/mL) measured by ELISA, as a marker of the pro-fibrotic pathway.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in malondialdehyde (MDA)
Serum/plasma MDA concentration (ng/mL) measured by ELISA, as a marker of lipid peroxidation and oxidative stress.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in asymmetric dimethylarginine (ADMA)
Serum/plasma ADMA concentration (ng/mL) measured by ELISA, as a marker of endothelial dysfunction.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in systolic blood pressure
Systolic blood pressure (mmHg).
Time frame: Baseline (Day 0) and Day 30 after injection
Change in diastolic blood pressure
Diastolic blood pressure (mmHg).
Time frame: Baseline (Day 0) and Day 30 after injection
Change in 24-hour urine output
Urine volume (mL) collected over 24 hours, as a measure of fluid balance.
Time frame: Baseline (Day 0) and Day 30 after injection
Degree of peripheral (extremity) edema
Clinical observation of the degree of extremity edema, as a measure of fluid balance.
Time frame: Baseline (Day 0) and Day 30 after injection
Change in body weight
Body weight (kg).
Time frame: Baseline (Day 0) and Day 30 after injection
Change in body mass index (BMI)
BMI (kg/m\^2) calculated from body weight and height.
Time frame: Baseline (Day 0) and Day 30 after injection
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →
Nurhasan Agung Prabowo