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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xiaosong Chen
- Número de teléfono: +86 13365910035
- Correo electrónico: chenxiaosong74@163.com
Copia de seguridad de contactos de estudio
- Nombre: Guang Yang
- Número de teléfono: +86 13077009115
- Correo electrónico: yangguangoooo@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exosomes + Sodium Hyaluronate Group
|
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.
|
|
Comparador activo: hUC-MSC-derived Exosome Monotherapy Group
|
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.
|
|
Comparador activo: Sodium Hyaluronate Monotherapy Group
|
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.
|
|
Comparador de placebos: Normal Saline Control Group
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bladder Mucosal Cystoscopic Score
Periodo de tiempo: 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.
|
From baseline to completion of the 6-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Lower Urinary Tract Symptom Severity Score
Periodo de tiempo: From baseline to completion of the 6-month follow-up
|
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
Periodo de tiempo: From baseline to completion of the 6-month follow-up
|
From baseline to completion of the 6-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026KY465-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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