- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01571817
Pancreatic Islet Transplantation Into the Gastric Submucosa
Treatment of Type I Diabetes by Pancreatic Islet Transplantation Into The Gastric Submucosa
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The overall objective of this pilot project is to evaluate the safety and efficacy of the gastric submucosal space as a novel site for clinical islet transplantation. Safety will be evaluated by the monitoring of side effects such as post procedural GI complications, frequency of hypo and hyperglycemic events, and immunosuppression side effects. Efficacy will be determined by accepted measures including insulin independence, long term glucose control, and reduction/elimination of hypoglycemic events.
The site has several physiologic attributes that may improve the outcomes of islet transplantation compared with the conventional intraportal transplant site.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
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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:
Key Inclusion Criteria:
- Primary islet allotransplant
- Type I diabetes mellitus for a minimum of 5 years
One or more of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
- Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (>2 hospital admissions in the previous year), erratic glucose profiles (MAGE>120 mg/dL), or disruption in lifestyle of danger to life, self or others
- Reduced awareness of hypoglycemia or >1 episode in the last 1.5 years of severe hypoglycemia
- Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of Intensive management efforts with the diabetes care team)
- Progressive secondary complications as defined by (i) a new proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) symptomatic autonomic neuropathy (as defined by postural hypotension or neuropathic bladder)
- Age 18 and older
- Patients who have a renal transplant must have received their transplant at least 3 months previously and must have stable renal function (see exclusion criteria below)
- Must be able to give written informed consent
Exclusion Criteria:
Key Exclusion Criteria:
- Lymphopenia (<1000/µL) or leukopenia ( <3000 total leukocytes/µL)
- Presence of panel-reactive anti-HLA antibody >20%
- Positive lymphocytotoxic cross-match using donor lymphocytes and serum
- Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM)
- Calculated or measured GFR < 50 ml/min/m2 in patients without a renal transplant.
- Calculated or measured GFR < 40 ml/min/m2 in patients with a renal transplant.
- Portal hypertension or history of significant liver disease
- History of malignancy within 10 years (except for treated basal or squamous cell CA of the skin)
- Active peptic ulcer disease or other gastric mucosal abnormalities as identified on screening endoscopy
- Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications
- Untreated proliferative retinopathy
- Pregnancy or breastfeeding
- Female subjects not post-menopausal or surgically sterile who are sexually active but not using an acceptable method of contraception
- Active infections
- Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
- Major ongoing psychiatric illness
- Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
Any condition that in the opinion of the Principal Investigator does not allow safe participation in the study
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Study intervention
endoscopically-guided intestinal submucosal transplantation of Isolated Human Pancreatic Islets in a type 1 diabetic patient
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Periodo de tiempo: Six months
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Hypo- and Hyper-glycemia limits for blood glucose related risks; during procedure, abdominal pain, duodenal hemorrhage, and duodenal perforation post-procedure, fever, cytokine release syndrome (to the thymoglobulin), immunosuppression related issues
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Six months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew M Posselt, M.D., Ph.D., University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Islet-Tx-Sub-DERC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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