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Can stem cell exosomes repair the peritoneum in dialysis patients?

NCT ID NCT07791667

Disease control Sponsor: Zhujiang Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a single dose of mesenchymal stem cell-derived exosomes, added to dialysis fluid and infused into the abdomen, is safe and tolerable for adults with peritoneal dialysis-related dysfunction. Researchers will give increasing doses to small groups and monitor for side effects. They will also check if the treatment improves the peritoneum's ability to filter and remove fluid. The goal is to find a safe dose for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mesenchymal stem cell-derived exosomes (MSC-Exos) added to dialysis fluid and infused into the abdomen
What this could lead to
If safe and effective, this could lead to a new treatment that restores peritoneal function, helping dialysis patients avoid switching to hemodialysis.
What could go wrong
This is an early, small phase 1 trial with only 12 participants, so results may not apply broadly. Risks include allergic reactions or peritoneal irritation, and the treatment may not improve function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who have been on continuous peritoneal dialysis for more than 1 year. 2. Age ≥ 18 years. 3. 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). Exclusion Criteria: 1. Patients with acute renal failure or chronic renal failure who can be temporarily weaned from dialysis. 2. Patients with malignant tumors, active infections, or severe malnutrition. 3. Patients with severe hepatic failure or cirrhosis. 4. Patients with severe cardiovascular disease, severe heart failure (NYHA Class IV or higher), or active systemic diseases. 5. Patients with peritonitis within the past 3 months or currently experiencing peritonitis. 6. Patients with encapsulating peritoneal sclerosis (EPS). 7. Patients with peritoneal dialysis catheter dysfunction. 8. Planned or ongoing pregnancy. 9. Simultaneous participation in another interventional clinical trial or drug study.

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As listed by the trial registrant

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Peritoneal dysfunction

How to take part

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  1. The official record

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