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

Launched by RODOLFO ALEJANDRO · Nov 25, 2013

Keywords

ClinConnect Summary

This clinical trial is exploring ways to prevent new sensitization in patients who have received islet transplants for Type 1 Diabetes after their transplant has completely failed. Sensitization can make it harder for patients to receive future transplants. The study is taking place at a single center and is open to both men and women aged 18 to 70 who have had at least one islet transplant and are currently experiencing low insulin production, indicated by a specific blood test result.

To participate, individuals must be mentally stable and able to follow the study guidelines. However, those with certain health issues, like active infections, severe heart problems, or a history of substance abuse, will not be eligible. Participants will be closely monitored throughout the study, and they can expect to receive care and support as part of their involvement. This trial is currently recruiting participants, and it aims to help improve the outcomes for future transplant candidates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients age 18-70 years of age.
• • 2. Ability to provide written informed consent.
• • 3. Mentally stable and able to comply with the procedures of the study protocol.
• • 4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
• • 5. History of at least one islet transplant.
• • 6. Stimulated C-peptide \<0.3 ng/ml.
• Exclusion Criteria:
• • 1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
• • 2. For female participants: Positive pregnancy test or presently breast-feeding.
• • 3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
• • 4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
• • 5. Known active alcohol or substance abuse.
• • 6. 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%.
• • 7. 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.
• • 8. Evidence of inter-current infection.
• • 9. Active peptic ulcer disease
• • 10. History on non-adherence to prescribed regimens including immunosuppression.
• • 11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.