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

NCT07665619 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2026KY465-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Radiation Cystitis

Keywords

Radiation Cystitis; hUC-MSC-derived exosomes; Sodium hyaluronate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Lower Urinary Tract Symptom Severity Score

  From baseline to completion of the 6-month follow-up

• Frequency of Hematuria Episodes

  From baseline to completion of the 6-month follow-up

Study Arms (4)

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)

Interventions

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.

Exosomes + Sodium Hyaluronate Group; hUC-MSC-derived Exosome Monotherapy Group

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.

Exosomes + Sodium Hyaluronate Group; Sodium Hyaluronate Monotherapy Group

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.

Normal Saline Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Interventions

Hyaluronic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Xiaosong Chen

CONTACT

+86 13365910035; chenxiaosong74@163.com

Guang Yang

CONTACT

+86 13077009115; yangguangoooo@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07