RecruitingNot Applicable

Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

United States18 participantsStarted 2009-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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 18-70 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.

Exclusion criteria

✕. 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.

What they're measuring

allosensitization after complete islet graft loss

Timeframe: 3 years

Trial details

NCT IDNCT01999361

SponsorRodolfo Alejandro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials