Islet Allotransplantation With Steroid Free Immunosuppression - Full Text View

Sponsors and Collaborators:	University Hospital, Lille Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00446264

Purpose

The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected.

This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

Condition	Intervention	Phase
Type 1 Diabetes Hypoglycemia Metabolic Lability	Procedure: islet transplantation Drug: dacluzimab - sirolimus - tacrolimus	Phase II

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia Islet Cell Transplantation

Drug Information available for: Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sequential Islet Transplantation With Steroid Free Immunosuppression for Type 1 Diabetes

Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:

. The proportion of patients with full graft function (insulin independence, HbA1c under 6.5%, basal C-peptide above 0.5 ng/mL, no hypoglycemia) at one year

Secondary Outcome Measures:

Initial graft function
Insulin endogenous secretion
Graft survival
Adverse events

Estimated Enrollment:	14
Study Start Date:	May 2003
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

type 1 diabetes documented for more than 5 years
arginine stimulated C-peptide lower than 0.2 ng/mL
one of the following:hypoglycemia unawareness OR metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year.

Exclusion Criteria:

body mass index greater than 28 kg/m2
non stable arteriopathy or heart disease
active infection
previous transplantation
hyperimmunization
insulin daily needs above 1.2 U/Kg
creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d
malignancy
smoking
desire for pregnancy
psychiatric disorders
lack of compliance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446264

Locations

France
University Hospital of Lille
Lille, France, 59037

Sponsors and Collaborators

University Hospital, Lille

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator:	Francois Pattou, MD	University Hospital, Lille
Principal Investigator:	Marie-Christine Vantyghem, MD PhD	University Hospital, Lille
Principal Investigator:	Julie Kerr-Conte, PhD	Université de Lille 2

More Information

Study ID Numbers:	PHRC 2001
Study First Received:	March 9, 2007
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00446264
Health Authority:	France : Agence Francaise de securité sanitaire de l'alimentation et des produits de sante

Keywords provided by University Hospital, Lille:

diabetes
hypoglycemia

Study placed in the following topic categories:

Sirolimus
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Tacrolimus
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009