Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Recruiting now · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Key facts
- Study ID
- NCT01999361
- Run by
- Rodolfo Alejandro
- People needed
- 18
- Starts
- 2009-01-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients age 18-70 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
- History of at least one islet transplant.
- Stimulated C-peptide <0.3 ng/ml.
You may not qualify if…
- Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
- For female participants: Positive pregnancy test or presently breast-feeding.
- History of active infection including hepatitis B, hepatitis C, HIV, or TB.
- Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
- Known active alcohol or substance abuse.
- Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction <30%.
- History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
- Evidence of inter-current infection.
- Active peptic ulcer disease
- History on non-adherence to prescribed regimens including immunosuppression.
- PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
Where it is running
- Diabetes Research Institute — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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