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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rodolfo Alejandro
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

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.