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 range18 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Male and female patients age 18 to 70 years of age.
ā. Ability to provide written informed consent.
ā. Mentally stable and able to comply with the procedures of the study protocol.
ā. Insulin-dependent diabetes mellitus
ā. Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
ā. Involvement in intensive diabetes management, defined by at least 3 injections daily or insulin pump therapy.
ā. Meets at least one of the following criteria despite intensive efforts made in close cooperation with their diabetic care team:
ā. Uncontrolled Hypertension (SBP\>160 or DBP\>100)
ā. For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
ā. 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.
ā. 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.
ā. 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.