Brief 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 brittle type 1, insulin-dependent diabetes mellitus and to improve their metabolic control.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Jul 2003

Longer than P75 for phase_1

Geographic Reach

2 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

July 1, 2003

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed

Last Updated

March 2, 2012

Status Verified

March 1, 2012

First QC Date

May 2, 2006

Last Update Submit

March 1, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

islet transplantationbrittle diabetessevere hypoglycemiatype 1 diabetes mellitus

Outcome Measures

Primary Outcomes (4)

The rate of insulin-independence, judged upon the following criteria : HbA1c < 6.1%,
post-prandial blood glucose < 180 mg/dl, mean amplitude of glycemic excursion (MAGE index)
< 60 mg/dl, basal C-peptide > 0.5 ng/ml. This insulin independent rate will be assessed 6 months
and 12 months following transplantation.

Secondary Outcomes (3)

The rate of success according to the DiaCell composite score defined by the following 4 items : functional islet graft, defined by a basal C-peptide > 0.5 ng/ml;
good metabolic control, defined by HbA1c ≤ 6.5%; disappearance of hypoglycemic events; reduction in exogenous insulin needs ≥ 30%.
Morbidity and quality of life will also be assessed.

Interventions

human pancreatic islet transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes mellitus
Disease duration \> 5 years
Despite intensive insulin therapy with tight endocrinologist supervision, persistence of the following conditions : hypoglycemia unawareness (\< 54 mg/dl) ; brittleness with at least two episodes of severe hypoglycemia ((defined by the need for assistance to correct the blood glucose level) or ketoacidosis per year , or often enough that the diabetologist judges the frequency to be life-threatening, the risk of transplantation and immunosuppression being judged to be less than the risk of the spontaneous course of uncontrolled diabetes
Basal and stimulated plasma C-peptide \< 0.2 ng/ml
Creatinine clearance ≥ 50 ml/min/1.73 m2 and proteinuria \< 0.5 g/24h

You may not qualify if:

Severe cardiovascular disease (recent myocardial infarction, unstable coronaropathy…)
Severe systemic infection, including hepatitis C or B viral infection, HIV infection or tuberculosis
Past or present neoplasia (with the exception of non melanoma skin cancers)
Body weight \> 70 kg in women and BW \> 75 kg in men or BMI \> 26
Stimulated C-peptide ≥ 0.3 ng/ml upon Glucagon or Arginine stimulation
Age \< 18 years or \> 65 years
Creatinine clearance \< 50 ml/min/1.73 m2
Albuminuria \> 300 mg /24h or proteinuria \> 0.5 g/24h
Hemoglobinemia \< 120 g/l in women or \< 130 g/l in men
Liver disease (enzymes \> 1.5 N) such as cirrhosis or hepatitis
Liver hemangioma
Untreated proliferating diabetic retinopathy
Pregnancy, lactation, pregnancy project or absence of efficient contraception
Previous transplantation or immunization as judged by anti-HLA antibodies (\> 20%)
Insulin needs \> 0.7 IU/kg/d or \> 50 IU
+11 more criteria

Contact the study team to confirm eligibility.