Improving Single Donor Success Rate in Clinical Islet Transplantation using Alpha-1 Antitrypsin (Aralast NP)

An Outline of This Clinical Trial

We have learned that there is general inflammation at the time of the islet transplant that is not fully controlled with our standard medications. We believe this inflammation may cause some islet cell death around the time of transplant. Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage during times of inflammation. Alpha-1 Antitrypsin (Aralast NP) is an approved drug used to treat people with Alpha-1 Antitrypsin deficiency. There have been studies in islet transplant in monkeys using this medication, and it has shown to protect the islets from inflammation. In this clinical trial, we are using Alpha-1 Antitrypsin to study its effect on cell death caused by general inflammation in addition to our current Standard of Care induction regimen medications used in islet transplant.

If you choose to participate, you will receive Alpha-1 Antitrypsin (AAT) study drug intravenously in 4 doses over 15 days around the time of their transplant. The islets you are going to receive will also be prepared in a solution of AAT. After the transplant, you will be followed clinically under Standard of Care. Study staff will review your clinical chart and the routine testing (including any blood work, imaging, insulin dosing, glucose monitoring records, hypoglycemia assessments) which you will complete at routine follow-ups.

Patient Eligibility

You may be eligible for this study if you are an adult (ages 18 to 68) with Type 1 diabetes (diagnosed for at least 5 years), assessed and deemed appropriate to activate on the waiting list for islet transplantation at the Clinical Islet Transplant Program.