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Can stem cell exosomes heal Radiation-Damaged bladders?

NCT ID NCT07665619

Disease control Sponsor: Fujian Medical University Union 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 4 times

Summary

This early-phase trial tests whether a combination of stem cell exosomes and sodium hyaluronate, instilled directly into the bladder, can safely treat radiation cystitis—a painful condition causing bleeding and urinary problems after pelvic radiotherapy. 48 women aged 18-80 will be randomly assigned to one of four groups: the combination, exosomes alone, sodium hyaluronate alone, or a saline placebo. Treatment is given once a week for 4 weeks, with follow-up at 1, 3, and 6 months to check bladder healing, symptoms, and safety.

What this could mean

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

Active substance
human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate
What this could lead to
If it works, this could offer a new treatment to repair bladder damage and reduce bleeding in people with radiation cystitis.
What could go wrong
This is a very early (Phase 1) trial with only 48 participants, so results may not apply to everyone. The treatment involves bladder catheterization, which carries infection and discomfort risks.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 48 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 to 80 years

Sex

Female participants only

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: * Female participants aged 18-80 years. * History of pelvic radiotherapy, with completion of radiotherapy at least 6 months prior to enrollment. * Clinically diagnosed with radiation cystitis accompanied by persistent lower urinary tract symptoms, such as urinary frequency, urgency, hematuria, or related symptoms. * Able and willing to provide written informed consent. Exclusion Criteria: * Acute urinary tract infection or active tuberculous cystitis. * Bladder tumor or bladder metastasis from other malignant tumors. * Severe cardiac, pulmonary, hepatic, or renal dysfunction (e.g., ALT/AST \>3 times the upper limit of normal or serum creatinine above the upper limit of normal). * Pregnant or breastfeeding women. * Known allergy to sodium hyaluronate or stem cell-derived products. * Participation in another clinical trial within the past 3 months.

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Conditions

The condition(s) this trial relates to.

radiation cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiation cystitis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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