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IMMEDIATE RETURN OF ISLET FUNCTION AND INSULIN INDEPENDENCE AFTER SIMULTANEOUS INTRA AND EXTRAHEPATIC TRANSPLANTATION OF UNPURIFIED AUTOLOGOUS ISLETS IN TOTAL PANCREATECTOMY AND ISLET CELL TRANSPLANTATION
Patrick T. Wang
*, Onur Kutlu, Xiumin Xu, Jodie A. Barkin, Jose M. Martinez, Camillo Ricordi
University of Miami Miller School of Medicine, Miami, FL
Background: Total Pancreatectomy and Autologous Islet Transplantation (TPAIT) is a therapeutic option for individuals with chronic pancreatitis or conditions requiring total pancreatectomy. This therapy aims to restore endogenous insulin production, consequently restoring quality of life and functionality. In this study, we investigated the outcomes of two patients undergoing TPAIT with two modifications. The first modification is a dual transplant site method using the colonic mesentery in addition to the portal vein, which would ideally decrease the likelihood of portal hypertension in TPAIT patients. The second modification is avoiding the final purification step in AIT. We hypothesize that this will increase the yield of islet cells while not significantly decreasing the odds of successful transplantation.
Method: Two patients with chronic pancreatitis and severe pain (narcotic dependency) underwent total pancreatectomy followed by AIT. Patient 1(female, 44) had AML, thyroid cancer, PRSS1, CLDN2 mutations, and gastroparesis. Patient 2 (female, 42) had PRSS1, GGT1 mutations, and gastric bypass. Both had near-normal islet function and good glycemic control pre-surgery. Islets were isolated using the Ricordi chamber and automated method, yielding 674,976 and 379,246 IEQ with purity of <10 and 15%, for Patient 1 and Patient 2, respectively. Viability (FDA/PI), potency (SI - stimulation index) and cell product volumes were 92%, 6.49 SI, 30 ml, and 89%, 3.55 SI,10 ml for Patient 1 and Patient 2 respectively. Islet cells were infused into the portal vein until pressure reached 20 mmHg, and the excess volume was added into the transverse colon mesentery.
Results: Both patients achieved insulin independence within 3 months, although Patient 2 experienced occasional hypoglycemia. HbA1c levels were 5.7% for Patient 1 and 5.9% for Patient 2, at 4 months post AIT. Both reported significant pain reduction and decreased narcotic use. No transplant-related complications were observed.
Conclusion: This approach demonstrates using unpurified islet cells to avoid the purification stem and associated loss of islets, while using a dual transplant site technique to avoid portal hypertension, are viable modifications to the traditional TPAIT approach. Additional clinical trials are needed to validate this alternative islet transplant approach.
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