The Therapeutic Potential of Mesenchymal Stem Cell-derived Exosomes in Peritoneal Dysfunction
A Phase I, Single-center, Open-label Study to Evaluate the Safety, Tolerability, and Dose-finding of Mesenchymal Stem Cell-derived Exosomes in the Treatment of Peritoneal Dialysis-related Peritoneal Dysfunction
The goal of this clinical trial is to learn if a single intraperitoneal infusion of mesenchymal stem cell-derived exosomes (MSC-Exos) is safe and tolerable in adults with peritoneal dialysis-related peritoneal failure. It will also explore whether MSC-Exos might improve how well the peritoneum works (ultrafiltration and solute transfer).
The main questions it aims to answer are:
What is the highest single dose of MSC-Exos that can be given safely without causing unacceptable side effects? (This helps find the maximum tolerated dose and the dose to use in future phase II studies.)
What medical problems (adverse events) do participants experience after receiving MSC-Exos?
Does MSC-Exos show any early signs of improving ultrafiltration volume and solute transport across the peritoneum?
Researchers will test increasing doses of MSC-Exos in small groups of participants. Each participant will receive one dose of MSC-Exos added to their usual 1.5% glucose dialysis solution (2 litres), which is then left in the abdominal cavity for 8 hours. The study does not use a placebo; instead, different dose levels are tested one after another to find the safest and most promising dose.
Participants will:
Receive a single intraperitoneal infusion of MSC-Exos through their dialysis catheter
Be monitored closely before the infusion；
Attend follow-up visits at 24 hours, 72 hours, 2 weeks, and 4 weeks after the dose;
Have blood and peritoneal effluent samples taken at each visit to check for safety ;
Have their ultrafiltration volume and solute transport ability measured at baseline and 4 weeks after the dose to see if any changes occur.
All participants will be closely observed for any side effects. The results will help decide whether further studies are warranted.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xun T Chief physicians
- Número de teléfono: +86 20 6278 2305
- Correo electrónico: 1847672118@qq.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who have been on continuous peritoneal dialysis for more than 1 year.
- Age ≥ 18 years.
Patients meeting at least one of the following criteria for peritoneal ultrafiltration insufficiency:
- Standard PET-confirmed ultrafiltration failure: 4-hour ultrafiltration volume < 400 mL using 4.25% glucose dialysate, or < 100 mL using 2.5% glucose dialysate; ② 1-hour sodium dip < 5 mmol/L and/or 1-hour sodium sieve ratio ≤ 0.03 using 4.25% glucose dialysate; ③ Inability to maintain fluid balance, as evidenced by persistent edema/heart failure symptoms, NT-proBNP >11215.2 ng/L, or bioimpedance spectroscopy-assessed overhydration (OH) >2 L (after excluding non-peritoneal causes).
Exclusion Criteria:
- Patients with acute renal failure or chronic renal failure who can be temporarily weaned from dialysis.
- Patients with malignant tumors, active infections, or severe malnutrition.
- Patients with severe hepatic failure or cirrhosis.
- Patients with severe cardiovascular disease, severe heart failure (NYHA Class IV or higher), or active systemic diseases.
- Patients with peritonitis within the past 3 months or currently experiencing peritonitis.
- Patients with encapsulating peritoneal sclerosis (EPS).
- Patients with peritoneal dialysis catheter dysfunction.
- Planned or ongoing pregnancy.
- Simultaneous participation in another interventional clinical trial or drug study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dose Level 1 (5×10⁹ particles)
|
MSC-Exos will be added to 2 L of 1.5% glucose peritoneal dialysis fluid, which will be administered via intraperitoneal infusion and retained for 8 hours.
|
|
Experimental: Dose Level 2 (2.5×10¹⁰ particles)
|
MSC-Exos will be added to 2 L of 1.5% glucose peritoneal dialysis fluid, which will be administered via intraperitoneal infusion and retained for 8 hours.
|
|
Experimental: Dose Level 3 (1×10¹¹ particles)
|
MSC-Exos will be added to 2 L of 1.5% glucose peritoneal dialysis fluid, which will be administered via intraperitoneal infusion and retained for 8 hours.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs)
Periodo de tiempo: Within 72 hours post-administration
|
Number of participants with MSC-Exos-related DLTs, defined as grade ≥3 local peritoneal reactions (abdominal pain / signs of peritonitis) or systemic allergic reactions assessed by CTCAE v5.0.
Local reactions will be objectively supported by peritoneal effluent white blood cell count and polymorphonuclear (PMN) cell percentage.
|
Within 72 hours post-administration
|
|
Incidence of Serious Adverse Events (SAEs)
Periodo de tiempo: Up to 4 weeks post-administration
|
Number of participants experiencing SAEs during the entire study period.
Safety monitoring includes serial assessments of complete blood count, C-reactive protein (CRP), and liver/kidney function tests (ALT, AST, creatinine, BUN).
|
Up to 4 weeks post-administration
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in 4-hour Ultrafiltration Volume
Periodo de tiempo: Baseline and Week 4
|
Change from baseline to Week 4 in 4-hour ultrafiltration volume during modified peritoneal equilibration test (PET).
|
Baseline and Week 4
|
|
Change in 4-hour D/Pcr Ratio
Periodo de tiempo: Baseline and Week 4
|
Change from baseline to Week 4 in 4-hour dialysate-to-plasma creatinine (D/Pcr) ratio during modified PET.
|
Baseline and Week 4
|
|
Change in 1-hour Sodium Dip
Periodo de tiempo: Baseline and Week 4
|
Change from baseline to Week 4 in 1-hour sodium dip (absolute decrease in serum sodium) during modified PET.
|
Baseline and Week 4
|
|
Change in Sodium Sieve
Periodo de tiempo: Baseline and Week 4
|
Change from baseline to Week 4 in sodium sieve, calculated as the ratio of dialysate sodium at 1 hour to baseline plasma sodium during modified PET.
|
Baseline and Week 4
|
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
Otros números de identificación del estudio
- 2025-KY-327-02
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.
producto fabricado y exportado desde los EE. UU.
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