Islet Transplant for Type 1 or Surgical Diabetes (NCT01606475) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Islet Transplant for Type 1 or Surgical Diabetes
United States
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:
1. islet transplant alone
2. simultaneous islet-kidney transplant, or 3)islet after kidney transplant.
Who can participate
Age range
18 Years – 70 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
. Male and female patients age 18 to 70 years of age.
. Ability to provide written informed consent.
. Mentally stable and able to comply with the procedures of the study protocol.
. Insulin-dependent diabetes mellitus
. Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
. Involvement in intensive diabetes management, defined by at least 3 injections daily or insulin pump therapy.
. Meets at least one of the following criteria despite intensive efforts made in close cooperation with their diabetic care team:
Exclusion criteria
. HbA1c \>10%.
. Untreated proliferative diabetic retinopathy.
. Uncontrolled Hypertension (SBP\>160 or DBP\>100)
. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
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.
. Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for use of prednisone \<5 mg per day for kidney transplant recipients or physiologic hydrocortisone replacement.
. Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient.