E10.7 Z94.0
Conditions
Interventions
Group 1: Percutananeous infusion of isolated islets via the portal vene into the liver
Aim >10.000 IEq / kg BW (in multiple transplantations)
> 300.000 IEq per transplantation
Sponsors
Universitätsklinikum Freiburg
Komm. Leitender Ärztlicher Direktor, Vorstandsvorsitzender
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) over 5 years diabetes type 1 with secondary complications (2) kidney transplantation or combined pancreas-kidney transplantation with failure of the transplanted pancreas
Exclusion criteria
Exclusion criteria: a) Severe corneal disease: - Myocardial infarction during the last 6 months - non correctable coronary heart disease b) alcohol- or drug (incl. nicotine) abuse c) Psychiatric disease d) History of non-compliance to prescribed drugs e) Active infection f) Cancer g) BMI >26kg/m2; BW > 70kg (women), 75kg (man) h) Positive C-peptide answer to arginine stimulus i) Non signed „informed consent“ form j) Age 65 years k) Elevated liver enzymes l.) gallstones m) Haemangioma of the liver n) Untreated proliferative retinopathy o) Gravidity p) Sensitisation by prior transplantation (PRA-testing) q) Demand of insulin > 0.7 IU/kg/day r) HbA1C >12% s) Ability not to reach the university hospital Freiburg during 12 hours t) Untreated hyperlipidemia u) Further treatment with steroids v) Marcumar therapy w) Morbus Addison x) Kidney transplantation < 12 months y) Creatinin-Clearance < 40 ml/min z) Deterioration of the kidney function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin independence after single or if necessary multiple islet transplantations | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved blood glucose control and reduced hypoglycaemia unawareness resulting in reduced hypoglycaemic episodes | — |
Countries
Germany
Contacts
Public ContactN. Perakakis
Uniklinik Freiburg; Innere Med. II, Schwerpunkt Endokrinologie/Diabetologie
Outcome results
None listed