Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis
Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels.
So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.
This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.
In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Tehran, Irán (República Islámica de
- Royan Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- peritoneal dialysis for at least last two years and
- Ultrafiltration failure
- Both genders
- Age 18-70 years
- inform consent signing
Exclusion Criteria:
- Inability of patients to attend visits and regular testing
- Estimated lifetime less than one year
- Use of immunosuppressive drugs
- Pregnancy
- Malignancy
- Coagulative disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: AD-MSC
The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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Comparador de placebos: Placebo
The patients with ultra filtration failure (UFF) underwent Placebo injection.
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Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Systemic infection
Periodo de tiempo: 6months
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Evaluation the rate of systemic infection in patients with UFF after cell therapy.
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6months
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Hepatic failure
Periodo de tiempo: 6 months
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Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
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6 months
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Renal failure
Periodo de tiempo: 6 months
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Evaluation the rate of renal failure in patients with UFF after cell therapy.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Ratio of 4-hour dialysate/plasma creatinine (D/P Cr).
Periodo de tiempo: 6 months
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Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
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6 months
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Ratio of 4-hour dialysate/plasma urea (D/P urea )
Periodo de tiempo: 6 months
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Evaluation the change of D/P in patients with UFF after cell therapy.
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6 months
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Ratio of dialysate glucose concentrations (D/D glucose )
Periodo de tiempo: 6 months
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Evaluation the change of D/D glucose in patients with UFF after cell therapy.
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6 months
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peritoneal membrane transport function
Periodo de tiempo: 6 months
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Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
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6 months
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Glomerular filtration rate (GFR):
Periodo de tiempo: 6 months
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Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Soroosh Shekarchian, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- Director de estudio: Nasser Aghdami, MD,PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- Director de estudio: Gholamreza Pourmand, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- Director de estudio: Iraj Najafi, MD, Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
- Investigador principal: Sudabeh Alatab, MD, Sudabeh
- Investigador principal: Reza Moghadasali, PhD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- Royan-kidney-006
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Intravenous injection
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Prometic Biotherapeutics, Inc.Atlantic Research GroupTerminadoInmunodeficiencia PrimariaEstados Unidos