Mesenchymal Stem Cell Exosomes Alone or Combined With HUVEC Exosomes in Non-Dialysis Chronic Kidney Disease
NCT07922889, Phase 1, Phase 2, Completed, Nurhasan Agung Prabowo
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mesenchymal Stem Cell Exosomes Alone or Combined With HUVEC Exosomes in Non-Dialysis Chronic Kidney Disease | ClinicalTrials.gov |
| NCT number | NCT07922889 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 34 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Nurhasan Agung Prabowo | ClinicalTrials.gov |
| Conditions | Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease | ClinicalTrials.gov |
| Interventions | Human Wharton's jelly mesenchymal stem cell (HWJ-MSC) exosomes, Human umbilical vein endothelial cell (HUVEC) exosomes, Placebo (0.9% sodium chloride) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in estimated glomerular filtration rate (eGFR) | Baseline (Day 0) and Day 30 after injection | 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. | ClinicalTrials.gov |
| Primary | Change in serum creatinine | Baseline (Day 0) and Day 30 after injection | Serum creatinine (mg/dL) as a measure of retention of metabolic waste products. | ClinicalTrials.gov |
| Primary | Change in blood urea (BUN) | Baseline (Day 0) and Day 30 after injection | Serum urea / blood urea nitrogen (mg/dL) as a measure of retention of metabolic waste products. | ClinicalTrials.gov |
| Primary | Change in urine albumin-to-creatinine ratio (UACR) | Baseline (Day 0) and Day 30 after injection | UACR (mg/g) measured in a random (spot) urine sample, as an indicator of glomerular/podocyte structural damage and albumin leakage. | ClinicalTrials.gov |
| Secondary | Number of participants with adverse events | From injection (Day 1) through Day 30 | 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. | ClinicalTrials.gov |
| Secondary | Change in high-sensitivity C-reactive protein (hs-CRP) | Baseline (Day 0) and Day 30 after injection | Serum/plasma hs-CRP concentration (pg/mL) measured by ELISA, as a marker of persistent systemic chronic inflammation in CKD. | ClinicalTrials.gov |
| Secondary | Change in interleukin-6 (IL-6) | Baseline (Day 0) and Day 30 after injection | Serum IL-6 measured by ELISA, as the main pro-inflammatory cytokine to evaluate the systemic immunomodulatory effect of the exosomes. | ClinicalTrials.gov |
| Secondary | Change in transforming growth factor-beta1 (TGF-beta1) | Baseline (Day 0) and Day 30 after injection | Serum/plasma TGF-beta1 concentration (ng/mL) measured by ELISA, as a marker of the pro-fibrotic pathway. | ClinicalTrials.gov |
| Secondary | Change in malondialdehyde (MDA) | Baseline (Day 0) and Day 30 after injection | Serum/plasma MDA concentration (ng/mL) measured by ELISA, as a marker of lipid peroxidation and oxidative stress. | ClinicalTrials.gov |
| Secondary | Change in asymmetric dimethylarginine (ADMA) | Baseline (Day 0) and Day 30 after injection | Serum/plasma ADMA concentration (ng/mL) measured by ELISA, as a marker of endothelial dysfunction. | ClinicalTrials.gov |
| Other | Change in systolic blood pressure | Baseline (Day 0) and Day 30 after injection | Systolic blood pressure (mmHg). | ClinicalTrials.gov |
| Other | Change in diastolic blood pressure | Baseline (Day 0) and Day 30 after injection | Diastolic blood pressure (mmHg). | ClinicalTrials.gov |
| Other | Change in 24-hour urine output | Baseline (Day 0) and Day 30 after injection | Urine volume (mL) collected over 24 hours, as a measure of fluid balance. | ClinicalTrials.gov |
| Other | Degree of peripheral (extremity) edema | Baseline (Day 0) and Day 30 after injection | Clinical observation of the degree of extremity edema, as a measure of fluid balance. | ClinicalTrials.gov |
| Other | Change in body weight | Baseline (Day 0) and Day 30 after injection | Body weight (kg). | ClinicalTrials.gov |
| Other | Change in body mass index (BMI) | Baseline (Day 0) and Day 30 after injection | BMI (kg/m\^2) calculated from body weight and height. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)