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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.