Islet Transplant in Patients With Type I Diabetes
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Diabetes Mellitus, Type 1
In brief
The primary objective of this study is to demonstrate the safety of allogenic islet transplantation in type 1 diabetic patients performed at the University of Virginia. The purpose is to demonstrate that islet transplantation can be performed safely and reliably achieves better glycemic control than state-of-the-art insulin treatment in management of type 1 diabetic patients with brittle control and a history of severe hypoglycemic episodes with hypoglycemia unawareness.
Key facts
- Study ID
- NCT03698396
- Run by
- Kenneth Brayman, MD
- People needed
- 10
- Starts
- 2019-08-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2020-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 1 episode of severe hypoglycemia in the past 3 years
- Reduced awareness of hypoglycemia
- Must be a qualified candidate for pancreas transplant
You may not qualify if…
- Diagnosis of co-existing cardiac diseased (ie, recent myocardial infarction within 6 months or angiographic evidence of non-correctable coronary artery disease or evidence of ischemia on functional cardiac exam
- Active alcohol or substance abuse
- Psychiatric disorder this is unstable or uncontrolled on current medication
- History of non-compliance
- Active infection including hepatitis C, hepatitis B, HIV
- History of or active Tuberculosis
- Any history of cancer, except skin cancer
- History of stroke within past 6 months
- BMI > 27 kg/m2
- C-peptide fasting response to glucagon stimulation
- Inability to provide informed consent
- Creatinine Clearance < 60 ml/min
- Macroalbuminuria
- Baseline Hb <12 gm/dL
- Baseline liver function test outside normal ranges
- History of untreated proliferative retinopathy
- Positive pregnancy test or male subjects intent to procreate while on study
- Previous transplant (except islet transplant)
- Insulin requirement of > 0.7 IU/kg/day
- HbA1c . 12%
- Hyperlipidemia
- Under treatment for medical condition requiring chronic use of steroids
- Use of coumadin or other antiplatelet therapy
- History of Factor V deficiency
- History of Addison's disease
Where it is running
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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