Peritoneal DysfunctionPhase 1NCT07791667
The Therapeutic Potential of Mesenchymal Stem Cell-derived Exosomes in Peritoneal Dysfunction
A Phase 1 study testing MSC-Exos in people with Peritoneal Dysfunction, run by Zhujiang Hospital.
Trial summary
The goal of this clinical trial is to learn if a single intraperitoneal infusion of mesenchymal stem cell-derived exosomes (MSC-Exos) is safe and tolerable in adults with peritoneal dialysis-related peritoneal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dysfunction
- What is being tested?
- MSC-Exos
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been on continuous peritoneal dialysis for more than 1 year.
- Age ≥ 18 years.
- Patients meeting at least one of the following criteria for peritoneal ultrafiltration insufficiency:
- Standard PET-confirmed ultrafiltration failure: 4-hour ultrafiltration volume < 400 mL using 4.25% glucose dialysate, or < 100 mL using 2.5% glucose dialysate; ② 1-hour sodium dip < 5 mmol/L and/or 1-hour sodium sieve ratio ≤ 0.03 using 4.25% glucose dialysate; ③ Inability to maintain fluid balance, as evidenced by persistent edema/heart failure symptoms, NT-proBNP >11215.2 ng/L, or bioimpedance spectroscopy-assessed overhydration (OH) >2 L (after excluding non-peritoneal causes).
Who cannot join
- Patients with acute renal failure or chronic renal failure who can be temporarily weaned from dialysis.
- Patients with malignant tumors, active infections, or severe malnutrition.
- Patients with severe hepatic failure or cirrhosis.
- Patients with severe cardiovascular disease, severe heart failure (NYHA Class IV or higher), or active systemic diseases.
- Patients with peritonitis within the past 3 months or currently experiencing peritonitis.
- Patients with encapsulating peritoneal sclerosis (EPS).
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- Patients with peritoneal dialysis catheter dysfunction.
- Planned or ongoing pregnancy.
- Simultaneous participation in another interventional clinical trial or drug study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Single-center, Open-label Study to Evaluate the Safety, Tolerability, and Dose-finding of Mesenchymal Stem Cell-derived Exosomes in the Treatment of Peritoneal Dialysis-related Peritoneal Dysfunction
The goal of this clinical trial is to learn if a single intraperitoneal infusion of mesenchymal stem cell-derived exosomes (MSC-Exos) is safe and tolerable in adults with peritoneal dialysis-related peritoneal failure. It will also explore whether MSC-Exos might improve how well the peritoneum works (ultrafiltration and solute transfer).
The main questions it aims to answer are:
Read more
What is the highest single dose of MSC-Exos that can be given safely without causing unacceptable side effects? (This helps find the maximum tolerated dose and the dose to use in future phase II studies.)
What medical problems (adverse events) do participants experience after receiving MSC-Exos?
Does MSC-Exos show any early signs of improving ultrafiltration volume and solute transport across the peritoneum?
Researchers will test increasing doses of MSC-Exos in small groups of participants. Each participant will receive one dose of MSC-Exos added to their usual 1.5% glucose dialysis solution (2 litres), which is then left in the abdominal cavity for 8 hours. The study does not use a placebo; instead, different dose levels are tested one after another to find the safest and most promising dose.
Participants will:
Receive a single intraperitoneal infusion of MSC-Exos through their dialysis catheter
Be monitored closely before the infusion；
Attend follow-up visits at 24 hours, 72 hours, 2 weeks, and 4 weeks after the dose;
Have blood and peritoneal effluent samples taken at each visit to check for safety ;
Have their ultrafiltration volume and solute transport ability measured at baseline and 4 weeks after the dose to see if any changes occur.
All participants will be closely observed for any side effects. The results will help decide whether further studies are warranted.
- Conditions
- Peritoneal Dysfunction
- Being tested
- MSC-Exos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC-ExosBiological
MSC-Exos will be added to 2 L of 1.5% glucose peritoneal dialysis fluid, which will be administered via intraperitoneal infusion and retained for 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (5×10⁹ particles) | Experimental | Not described Receives: Biological: MSC-Exos |
| Dose Level 2 (2.5×10¹⁰ particles) | Experimental | Not described Receives: Biological: MSC-Exos |
| Dose Level 3 (1×10¹¹ particles) | Experimental | Not described Receives: Biological: MSC-Exos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Number of participants with MSC-Exos-related DLTs, defined as grade ≥3 local peritoneal reactions (abdominal pain / signs of peritonitis) or systemic allergic reactions assessed by CTCAE v5.0. Local reactions will be objectively supported by peritoneal effluent white blood cell count and polymorphonuclear (PMN) cell percentage.
Measured: Within 72 hours post-administration
Incidence of Serious Adverse Events (SAEs)
Number of participants experiencing SAEs during the entire study period. Safety monitoring includes serial assessments of complete blood count, C-reactive protein (CRP), and liver/kidney function tests (ALT, AST, creatinine, BUN).
Measured: Up to 4 weeks post-administration
Secondary outcomes (4)
Change in 4-hour Ultrafiltration Volume
Change from baseline to Week 4 in 4-hour ultrafiltration volume during modified peritoneal equilibration test (PET).
Measured: Baseline and Week 4
Change in 4-hour D/Pcr Ratio
Change from baseline to Week 4 in 4-hour dialysate-to-plasma creatinine (D/Pcr) ratio during modified PET.
Measured: Baseline and Week 4
Change in 1-hour Sodium Dip
Change from baseline to Week 4 in 1-hour sodium dip (absolute decrease in serum sodium) during modified PET.
Measured: Baseline and Week 4
Change in Sodium Sieve
Change from baseline to Week 4 in sodium sieve, calculated as the ratio of dialysate sodium at 1 hour to baseline plasma sodium during modified PET.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DysfunctionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Tang, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791667
- Sponsor's protocol ID
- 2025-KY-327-02
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Open-label Study to Evaluate the Safety, Tolerability, and Dose-finding of Mesenchymal Stem Cell-derived Exosomes in the Treatment of Peritoneal Dialysis-related Peritoneal Dysfunction
- ClinicalTrials.gov ID
- NCT07791667
- Acronym / sponsor ID
- 2025-KY-327-02
- Conditions
- Peritoneal Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a single intraperitoneal infusion of mesenchymal stem cell-derived exosomes (MSC-Exos) is safe and tolerable in adults with peritoneal dialysis-related peritoneal failure. It will also explore whether MSC-Exos might improve how well the peritoneum works (ultrafiltration and solute transfer).
The main questions it aims to answer are:
What is the highest single dose of MSC-Exos that can be given safely without causing unacceptable side effects? (This helps find the maximum tolerated dose and the dose to use in future phase II studies.)
What medical problems (adverse events) do participants experience after receiving MSC-Exos?
Does MSC-Exos show any early signs of improving ultrafiltration volume and solute transport across the peritoneum?
Researchers will test increasing doses of MSC-Exos in small groups of participants. Each participant will receive one dose of MSC-Exos added to their usual 1.5% glucose dialysis solution (2 litres), which is then left in the abdominal cavity for 8 hours. The study does not use a placebo; instead, different dose levels are tested one after another to find the safest and most promising dose.
Participants will:
Receive a single intraperitoneal infusion of MSC-Exos through their dialysis catheter
Be monitored closely before the infusion；
Attend follow-up visits at 24 hours, 72 hours, 2 weeks, and 4 weeks after the dose;
Have blood and peritoneal effluent samples taken at each visit to check for safety ;
Have their ultrafiltration volume and solute transport ability measured at baseline and 4 weeks after the dose to see if any changes occur.
All participants will be closely observed for any side effects. The results will help decide whether further studies are warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (5×10⁹ particles) | Experimental | Biological: MSC-Exos |
| Dose Level 2 (2.5×10¹⁰ particles) | Experimental | Biological: MSC-Exos |
| Dose Level 3 (1×10¹¹ particles) | Experimental | Biological: MSC-Exos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have been on continuous peritoneal dialysis for more than 1 year.
- Age ≥ 18 years.
- Patients meeting at least one of the following criteria for peritoneal ultrafiltration insufficiency:
Key exclusion criteria (9 listed)
- Patients with acute renal failure or chronic renal failure who can be temporarily weaned from dialysis.
- Patients with malignant tumors, active infections, or severe malnutrition.
- Patients with severe hepatic failure or cirrhosis.
- Patients with severe cardiovascular disease, severe heart failure (NYHA Class IV or higher), or active systemic diseases.
- Patients with peritonitis within the past 3 months or currently experiencing peritonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC-ExosMSC-Exos will be added to 2 L of 1.5% glucose peritoneal dialysis fluid, which will be administered via intraperitoneal infusion and retained for 8 hours. | Biological | Dose Level 1 (5×10⁹ particles), Dose Level 2 (2.5×10¹⁰ particles), Dose Level 3 (1×10¹¹ particles) |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Within 72 hours post-administration
Number of participants with MSC-Exos-related DLTs, defined as grade ≥3 local peritoneal reactions (abdominal pain / signs of peritonitis) or systemic allergic reactions assessed by CTCAE v5.0. Local reactions will be objectively supported by peritoneal effluent white blood cell count and polymorphonuclear (PMN) cell percentage.
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4 weeks post-administration
Number of participants experiencing SAEs during the entire study period. Safety monitoring includes serial assessments of complete blood count, C-reactive protein (CRP), and liver/kidney function tests (ALT, AST, creatinine, BUN).
4 secondary outcomes
Change in 4-hour Ultrafiltration Volume
Time frame: Baseline and Week 4
Change in 4-hour D/Pcr Ratio
Time frame: Baseline and Week 4
Change in 1-hour Sodium Dip
Time frame: Baseline and Week 4
Change in Sodium Sieve
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSC-Exos in people with Peritoneal Dysfunction, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xun T Chief physicians (+86 20 6278 2305, 1847672118@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Within 72 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.