An Early Phase 1 interventional study of Exosomes (hUC-MSC-Exo) and Sodium Hyaluronate (Hyalein) in Radiation Cystitis, sponsored by Fujian Medical University Union Hospital. Not yet recruiting. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Fujian Medical University Union Hospital · Early Phase 1, Interventional, and Treatment
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 48 is below the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →Fujian Medical University Union Hospital is the lead sponsor of 109 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Exosomes (hUC-MSC-Exo) · Drug: Sodium Hyaluronate (Hyalein)
Drug: Exosomes (hUC-MSC-Exo)
Drug: Sodium Hyaluronate (Hyalein)
Drug: Normal Saline (0.9% NaCl)
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.
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.
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.
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.
Time frame: From baseline to completion of the 6-month follow-up
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.
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2027, 16 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid
Fujian Medical University Union Hospital →