Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplan… (NCT00501709) | Clinical Trial Compass
CompletedPhase 1/2
Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus
United States10 participantsStarted 2007-02
Plain-language summary
Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Type 1 Diabetes
* Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(\>2 hospital admissions in the previous year), erratic glucose profiles(MAGE \>120mg/dL), or disruption in lifestyle(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 diabetes care team.
* Progressive secondary complications as defined by
* a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or
* urinary albumin excretion rate \>300mg/day but proteinuria \<3g/day; or
* symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)
Exclusion Criteria:
* Patient weighs more than 80kg or body mass index BMI\>28
* Patient's insulin requirement is \>55 Units/day.
* Current use of immunosuppressive agents.
* History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).
* Active peptic ulcer disease.
* Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.
* Untreated proliferative retinopathy.
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