Radiation CystitisEarly Phase 1NCT07665619
Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis
A Early Phase 1 study testing Exosomes (hUC-MSC-Exo), Sodium Hyaluronate (Hyalein) and Normal Saline (0.9% NaCl) in people with Radiation Cystitis, run by Fujian Medical University Union Hospital.
Trial summary
The goal of this clinical trial is to learn whether intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate is safe and effective for treating radiation cystitis. Radiation cystitis is a complication that may occur after pelvic radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Radiation Cystitis
- What is being tested?
- Exosomes (hUC-MSC-Exo), Sodium Hyaluronate (Hyalein) and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 1 Jun 2028
- Phase
- Early 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
The goal of this clinical trial is to learn whether intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate is safe and effective for treating radiation cystitis. Radiation cystitis is a complication that may occur after pelvic radiotherapy. Common symptoms include blood in the urine, frequent urination, urgent urination, and painful urination.
The main questions this study aims to answer are:
Read more
Can human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate improve blood in the urine in participants with radiation cystitis? Can this combined treatment help repair injury to the bladder lining and blood vessels? What discomfort or medical problems may occur during the treatment?
Researchers will compare four treatment approaches: human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate, human umbilical cord mesenchymal stem cell-derived exosomes alone, sodium hyaluronate alone, and normal saline as a control. By comparing these groups, researchers hope to find out whether the combined treatment works better than either treatment alone or the control treatment.
Participants will:
Be screened to confirm whether they are eligible for the study; Sign an informed consent form and complete baseline assessments; Be randomly assigned to one of four treatment groups; Receive intravesical instillation once a week for 4 weeks; Attend follow-up visits at 1 month, 3 months, and 6 months after treatment; Be assessed for blood in the urine, urinary symptoms, cystoscopy findings, quality of life, and safety.
This study may help provide a new treatment option for radiation cystitis and further evaluate the safety and early effectiveness of this treatment.
- Conditions
- Radiation Cystitis
- Being tested
- Exosomes (hUC-MSC-Exo), Sodium Hyaluronate (Hyalein), Normal Saline (0.9% NaCl)
- Keywords
- Radiation Cystitis, hUC-MSC-derived exosomes, Sodium hyaluronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosomes (hUC-MSC-Exo)Drug
Participants in this group will receive intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSC-Exo). After bladder emptying, a predefined dose of hUC-MSC-Exo preparation will be slowly instilled into the bladder through a sterile urinary catheter. Participants will be instructed to retain the instilled solution in the bladder for an appropriate period to allow sufficient contact with the bladder mucosa. The treatment will be administered once weekly for 4 consecutive weeks. Clinical symptoms, including urinary frequency, urgency, dysuria, hematuria, and treatment-related adverse events, will be monitored during treatment and follow-up.
Sodium Hyaluronate (Hyalein)Drug
Participants in this group will receive intravesical instillation of sodium hyaluronate (Hyalein) once weekly for 4 consecutive weeks. After bladder emptying, sodium hyaluronate will be slowly instilled into the bladder through a sterile urinary catheter and retained for an appropriate period. Clinical symptoms and treatment-related adverse events will be monitored during treatment and follow-up.
Normal Saline (0.9% NaCl)Drug
Participants will receive intravesical instillation of normal saline (0.9% NaCl). After bladder emptying, a predefined volume of normal saline will be slowly instilled into the bladder through a sterile urinary catheter and retained for an appropriate period. The treatment will be administered once weekly for 4 consecutive weeks. Clinical symptoms and adverse events will be monitored during treatment and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Exosomes + Sodium Hyaluronate Group | Experimental | Not described Receives: Drug: Exosomes (hUC-MSC-Exo); Drug: Sodium Hyaluronate (Hyalein) |
| hUC-MSC-derived Exosome Monotherapy Group | Active comparator | Not described Receives: Drug: Exosomes (hUC-MSC-Exo) |
| Sodium Hyaluronate Monotherapy Group | Active comparator | Not described Receives: Drug: Sodium Hyaluronate (Hyalein) |
| Normal Saline Control Group | Placebo comparator | Not described Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Mucosal Cystoscopic Score
The bladder mucosal condition will be assessed by cystoscopy using the Bladder Mucosal Cystoscopic Score. The score ranges from 0 to 12, with higher scores indicating more severe bladder mucosal injury and worse clinical outcome.
Measured: From baseline to completion of the 6-month follow-up
Secondary outcomes (2)
Change in Lower Urinary Tract Symptom Severity Score
Lower urinary tract symptom severity will be assessed using the International Prostate Symptom Score. The total score ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms and worse clinical outcome.
Measured: From baseline to completion of the 6-month follow-up
Frequency of Hematuria Episodes
Measured: From baseline to completion of the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start20 Jul 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation CystitisStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenXiaosong, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665619
- Sponsor's protocol ID
- 2026KY465-01
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis
- ClinicalTrials.gov ID
- NCT07665619
- Acronym / sponsor ID
- 2026KY465-01
- Conditions
- Radiation Cystitis
- Keywords
- Radiation Cystitis, hUC-MSC-derived exosomes, Sodium hyaluronate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Jun 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 whether intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate is safe and effective for treating radiation cystitis. Radiation cystitis is a complication that may occur after pelvic radiotherapy. Common symptoms include blood in the urine, frequent urination, urgent urination, and painful urination.
The main questions this study aims to answer are:
Can human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate improve blood in the urine in participants with radiation cystitis? Can this combined treatment help repair injury to the bladder lining and blood vessels? What discomfort or medical problems may occur during the treatment?
Researchers will compare four treatment approaches: human umbilical cord mesenchymal stem cell-derived exosomes combined with sodium hyaluronate, human umbilical cord mesenchymal stem cell-derived exosomes alone, sodium hyaluronate alone, and normal saline as a control. By comparing these groups, researchers hope to find out whether the combined treatment works better than either treatment alone or the control treatment.
Participants will:
Be screened to confirm whether they are eligible for the study; Sign an informed consent form and complete baseline assessments; Be randomly assigned to one of four treatment groups; Receive intravesical instillation once a week for 4 weeks; Attend follow-up visits at 1 month, 3 months, and 6 months after treatment; Be assessed for blood in the urine, urinary symptoms, cystoscopy findings, quality of life, and safety.
This study may help provide a new treatment option for radiation cystitis and further evaluate the safety and early effectiveness of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exosomes + Sodium Hyaluronate Group | Experimental | Drug: Exosomes (hUC-MSC-Exo), Drug: Sodium Hyaluronate (Hyalein) |
| hUC-MSC-derived Exosome Monotherapy Group | Active comparator | Drug: Exosomes (hUC-MSC-Exo) |
| Sodium Hyaluronate Monotherapy Group | Active comparator | Drug: Sodium Hyaluronate (Hyalein) |
| Normal Saline Control Group | Placebo comparator | Drug: Normal Saline (0.9% NaCl) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Exosomes (hUC-MSC-Exo)Participants in this group will receive intravesical instillation of human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSC-Exo). After bladder emptying, a predefined dose of hUC-MSC-Exo preparation will be slowly instilled into the bladder through a sterile urinary catheter. Participants will be instructed to retain the instilled solution in the bladder for an appropriate period to allow sufficient contact with the bladder mucosa. The treatment will be administered once weekly for 4 consecutive weeks. Clinical symptoms, including urinary frequency, urgency, dysuria, hematuria, and treatment-related adverse events, will be monitored during treatment and follow-up. | Drug | Exosomes + Sodium Hyaluronate Group, hUC-MSC-derived Exosome Monotherapy Group |
| Sodium Hyaluronate (Hyalein)Participants in this group will receive intravesical instillation of sodium hyaluronate (Hyalein) once weekly for 4 consecutive weeks. After bladder emptying, sodium hyaluronate will be slowly instilled into the bladder through a sterile urinary catheter and retained for an appropriate period. Clinical symptoms and treatment-related adverse events will be monitored during treatment and follow-up. | Drug | Exosomes + Sodium Hyaluronate Group, Sodium Hyaluronate Monotherapy Group |
| Normal Saline (0.9% NaCl)Participants will receive intravesical instillation of normal saline (0.9% NaCl). After bladder emptying, a predefined volume of normal saline will be slowly instilled into the bladder through a sterile urinary catheter and retained for an appropriate period. The treatment will be administered once weekly for 4 consecutive weeks. Clinical symptoms and adverse events will be monitored during treatment and follow-up. | Drug | Normal Saline Control Group |
Primary outcome
Bladder Mucosal Cystoscopic Score
Time frame: From baseline to completion of the 6-month follow-up
The bladder mucosal condition will be assessed by cystoscopy using the Bladder Mucosal Cystoscopic Score. The score ranges from 0 to 12, with higher scores indicating more severe bladder mucosal injury and worse clinical outcome.
2 secondary outcomes
Change in Lower Urinary Tract Symptom Severity Score
Time frame: From baseline to completion of the 6-month follow-up
Frequency of Hematuria Episodes
Time frame: From baseline to completion of the 6-month follow-up
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 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Exosomes (hUC-MSC-Exo), Sodium Hyaluronate (Hyalein) and Normal Saline (0.9% NaCl) in people with Radiation Cystitis, run by Fujian Medical University Union 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 6 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 8 Jul 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaosong Chen (+86 13365910035, chenxiaosong74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Mucosal Cystoscopic Score (time frame: From baseline to completion of the 6-month follow-up). 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 8 Jul 2026.