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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Bladder Mucosal Cystoscopic Score [Срок оценки: From baseline to completion of the 6-month follow-up]

Вторичные конечные точки (2)

• Change in Lower Urinary Tract Symptom Severity Score [Срок оценки: From baseline to completion of the 6-month follow-up]
• Frequency of Hematuria Episodes [Срок оценки: From baseline to completion of the 6-month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07665619 · 2026KY465-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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