Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis

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 Overview

• Status: Not yet recruiting
• Conditions: Radiation Cystitis
• Intervention / Treatment: Drug: Exosomes (hUC-MSC-Exo); Drug: Sodium Hyaluronate (Hyalein); Drug: Normal Saline (0.9% NaCl)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiaosong Chen; Phone Number: +86 13365910035; Email: chenxiaosong74@163.com
• Study Contact Backup: Name: Guang Yang; Phone Number: +86 13077009115; Email: yangguangoooo@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exosomes + Sodium Hyaluronate Group	Drug: 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: 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.
Active Comparator: hUC-MSC-derived Exosome Monotherapy Group	Drug: 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.
Active Comparator: Sodium Hyaluronate Monotherapy Group	Drug: 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.
Placebo Comparator: Normal Saline Control Group	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to completion of the 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to completion of the 6-month follow-up
Frequency of Hematuria Episodes		From baseline to completion of the 6-month follow-up

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Sodium hyaluronate; Radiation Cystitis; hUC-MSC-derived exosomes
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Glycosaminoglycans; Polysaccharides; Hyaluronic Acid; Saline Solution
• Other Study ID Numbers: 2026KY465-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No