Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft

Type 1 Diabetes Mellitus Clinical Trial

— GRAGIL1  

Official title:

Transplantation d'îlots pancréatiques allogéniques Adultes Pour le Traitement du diabète insulinodépendant. Etude GRAGIL 1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00639600
• Other study ID #: 95/CHUG/10/C2
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 14, 2008
• Last updated: May 28, 2010
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

Description:

The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus

• Disease duration > 5 years

• ketose antecedents

• Basal and stimulated plasma C-< 0.2 ng/ml,<0.06 nmol/l (glycemia must be measured simultaneously_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min)

• Established kidney graft = 6 months

• Current creatinine clearance: = 50 ml/min/1.73 m² and Proteinuria < 0.5 g/24h

• HbA1C< 12%

Exclusion Criteria:

• Hemostasis problems

• Documented hepatic pathology

• Patient under 18 or over 65 year-old

• Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI > 26

• Men with body weight > 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI > 26

• insuline needs > 0.7 U/kg/j or 50 U/j

• Serious life-threatening pathology

• untreated hyperlipidemia

• Hypersensitivity to drugs rapamycine-alike

• Liver disease (transaminases or total bilirubin = 3N)

• Failure to communicate or cooperate with the investigator

Exclusion criteria that are specific to the use of Rapamycine

• Hypercholesterolemia (> 350mg/dl, 9,1 mmol/l) not controlled

• Hypertriglyceridemia (> 500 mg/dl, 5,6 mmol/l) not controlled

• Leukocytes > 4500 /mm3 , neutrophils > 2000/ mm3, platelets > 100000/ mm3

• Any clinical or biological pathology that could interfere with the study

• Past or present neoplasia (with the exception of non melanoma skin cancers)

• Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.

• Pregnancy, lactation, pregnancy project or absence of efficient contraception

• Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Procedure:
• human pancreatic islet transplantation
human pancreatic islet transplantation

Locations

Country	Name	City	State
France	University Hospital	Besancon
France	University Hospital, Department of Endocrinology	Grenoble
France	University Hospital, Department of Endocrinology	Lyon
France	University Hospital, Department of Endocrinology	Montpellier
France	University Hospital, Department of Endocrinology	Nancy
France	University Hospital, Department of Endocrinology	Strasbourg
Switzerland	University Hospital, Department of Surgery	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of insulin-independence at 6 and 12 months after transplantation, duration of insulin-independence, survival curves		12 months	Yes
Secondary	Tolerance (Measurement of portal pressure during islet injection) Quality of life (Questionnaires SF-36 and DQOL at inclusion time, then every 6 months during their waiting period and then 6 months and 12 months after transplantation) Costs		12 months	No