Nitrite Infusion in Islet Cell Transplantation

Patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire
insulin-dependent diabetes due to islet cell destruction. Therefore, islet cell
autotransplantation is the optimal therapeutic approach for many of these patients. Islet
cell autotransplantation is typically done by excision of the pancreas, followed by isolation
of the islet cells and then infusion of these cells into the sinusoids of the liver.
Isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in
ischemia reperfusion (IR) injury and destruction of islet cells following infusion into the
sinusoids. Hence, strategies to prevent IR injury and subsequent islet cell destruction, such
as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance
islet cell survival following reperfusion, also decreasing long-term insulin requirement. The
purpose of this study is to determine if NO administered by infusion in patients undergoing
islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure
rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the
ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels
during procurement of the islet cells) during islet cell procurement, and decrease IR injury
following islet cell infusion. The primary endpoints of the study are exogenous insulin use,
HgbA1c levels post-operatively, and blood glucose levels.

Inclusion Criteria:

- Patients greater than or equal to 18 years of age

- Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart
Rose

- Subjects who can provide informed written consent and are willing to do so

Exclusion Criteria:

-Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)