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Islet Cell Transplantation for Treatment of Pancreatic Diseases
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Islet Cell Transplantation for Treatment of Pancreatic Diseases

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Gastroenterology & Hepatopancreatobiliary Medicine".

Deadline for manuscript submissions: closed (15 May 2021) | Viewed by 15757

Special Issue Editor

Dr. Beth Schrope

E-Mail Website
Guest Editor
Columbia University, Irving Med Ctr, New York City, NY, USA
Interests: pancreatic islet cell transplantation; minimally invasive surgery

Special Issue Information

Dear Colleagues,

Isolation of pancreatic islets, either allogeneic or autologous, is an important option for the treatment of numerous diseases of the pancreas. In the allogeneic setting, evidence has suggested that islet cells from cadaveric donors can serve as a robust treatment for type I diabetes. For patients with inherent diseases of the pancreas, most notably chronic pancreatitis, pancreatectomy with isolation and reimplantation of pancreatic islets can prevent or at least mitigate a brutal form of diabetes, type 3c diabetes. Other pancreatic diseases such as premalignant conditions (cystic disease, certain genetic mutations at high risk for eventual malignancy) are also potential applications of this procedure, with accumulating evidence. In this Special issue, we will explore the current status of both allogeneic and autologous islet cell transplantation, including challenges in islet isolation, implantation, and survival, immunosuppression for allogeneic recipients, and regulatory issues.

Dr. Beth Schrope
Guest Editor

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Keywords

  • allogenic islet cell transplantation
  • total pancreatectomy with autologous islet cell transplantation
  • type 3c diabetes
  • type 1 diabetes
  • chronic pancreatitis
  • intraductal papillary mucinous neoplasm

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Published Papers (6 papers)

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Research

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10 pages, 783 KiB  
Article
Evaluating the Prognostic Value of Islet Autoantibody Monitoring in Islet Transplant Recipients with Long-Standing Type 1 Diabetes Mellitus
by Roi Anteby, Aaron Lucander, Piotr J. Bachul, Jordan Pyda, Damian Grybowski, Lindsay Basto, Gabriela S. Generette, Laurencia Perea, Karolina Golab, Ling-jia Wang, Martin Tibudan, Celeste Thomas, John Fung and Piotr Witkowski
J. Clin. Med. 2021, 10(12), 2708; https://doi.org/10.3390/jcm10122708 - 19 Jun 2021
Cited by 6 | Viewed by 1821
Abstract
(1) Background: The correlation between titers of islet autoantibodies (IAbs) and the loss of transplanted islets remains controversial. We sought to evaluate the prognostic utility of monitoring IAbs in diabetic patients after islet transplantation (ITx); (2) Methods: Twelve patients with Type 1 diabetes [...] Read more.
(1) Background: The correlation between titers of islet autoantibodies (IAbs) and the loss of transplanted islets remains controversial. We sought to evaluate the prognostic utility of monitoring IAbs in diabetic patients after islet transplantation (ITx); (2) Methods: Twelve patients with Type 1 diabetes mellitus and severe hypoglycemia underwent ITx. Serum concentration of glutamic acid decarboxylase (GAD), insulinoma antigen 2 (IA-2), and zinc transport 8 (ZnT8) autoantibodies was assessed before ITx and 0, 7, and 75 days and every 3 months post-operatively; (3) Results: IA-2A (IA-2 antibody) and ZnT8A (ZnT8 antibody) levels were not detectable before or after ITx in all patients (median follow-up of 53 months (range 24–61)). Prior to ITx, GAD antibody (GADA) was undetectable in 67% (8/12) of patients. Of those, 75% (6/8) converted to GADA+ after ITx. In 67% (4/6) of patients with GADA+ seroconversion, GADA level peaked within 3 months after ITx and subsequently declined. All patients with GADA+ seroconversion maintained long-term partial or complete islet function (insulin independence) after 1 or 2 ITx. There was no correlation between the presence of IAb-associated HLA haplotypes and the presence of IAbs before or after ITx; (4) Conclusions: There is no association between serum GADA trends and ITx outcomes. IA-2A and ZnT8A were not detectable in any of our patients before or after ITx. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)
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9 pages, 557 KiB  
Article
Improved Glycemic Outcomes with Early Initiation of Insulin Pump Therapy in Pediatric Postoperative Total Pancreatectomy with Islet Autotransplantation
by Siobhan E. Tellez, Lindsey N. Hornung, Joshua D. Courter, Maisam Abu-El-Haija, Jaimie D. Nathan, Sarah A. Lawson and Deborah A. Elder
J. Clin. Med. 2021, 10(11), 2242; https://doi.org/10.3390/jcm10112242 - 21 May 2021
Cited by 6 | Viewed by 1689
Abstract
Total pancreatectomy with islet autotransplantation (TPIAT) is a surgical procedure for patients with chronic pancreatitis and poor quality of life. Euglycemia is critical for islet cell survival and engraftment. We reviewed clinical care practice and hypothesized that early in-hospital transition from intravenous insulin [...] Read more.
Total pancreatectomy with islet autotransplantation (TPIAT) is a surgical procedure for patients with chronic pancreatitis and poor quality of life. Euglycemia is critical for islet cell survival and engraftment. We reviewed clinical care practice and hypothesized that early in-hospital transition from intravenous insulin to insulin pump therapy, managed by an endocrine unit trained on post-surgical care, would improve glucose control and impact the length of hospital stay. We completed a retrospective analysis of 40 pediatric patients who underwent TPIAT. Comparative hospitalized postoperative groups included those who received insulin intravenously, followed by multiple daily injections, subsequently managed by pump therapy (n = 14), versus those who received insulin intravenously followed by early pump therapy provided on the endocrine unit trained to manage post-surgical patients (n = 26). The outcomes analyzed included percentage of blood glucoses in target (4.44–6.66 mmol/L (80–120 mg/dL)), hypoglycemia (<3.33 mmol/L (<60 mg/dL)) and hyperglycemia (>7.77 mmol/L (>140 mg/dL)), blood glucose variability, and length of hospital unit stay post-ICU. Hospitalized patients with early transition to pump therapy on a specialized endocrine unit had a higher proportion of glucose values in the target range (61% vs. 51%, p = 0.0003), a lower proportion of hyperglycemia (15% vs. 19%, p = 0.04), and a lower proportion of hypoglycemia, though not statistically significant (3.4% vs. 4.4%, p = 0.33). Early pump users also had lower variability in glucose values over 10 days post-intravenous insulin (p = 0.001), and the post-transition median length of stay was shorter by 5 days (median: 11.5 vs. 16.5 days, p = 0.005). Early in-hospital pump therapy managed by the specialized endocrine unit improved glucose outcomes and reduced the duration of in-unit stay. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)
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9 pages, 648 KiB  
Article
Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model
by Natalie Segev, Lindsey N. Hornung, Siobhan E. Tellez, Joshua D. Courter, Sarah A. Lawson, Jaimie D. Nathan, Maisam Abu-El-Haija and Deborah A. Elder
J. Clin. Med. 2021, 10(9), 1893; https://doi.org/10.3390/jcm10091893 - 27 Apr 2021
Cited by 11 | Viewed by 2644
Abstract
Hyperglycemia is detrimental to postoperative islet cell survival in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT). This makes continuous glucose monitoring (CGM) a useful management tool. We evaluated the accuracy of the Dexcom G6 CGM in pediatric intensive care unit patients following [...] Read more.
Hyperglycemia is detrimental to postoperative islet cell survival in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT). This makes continuous glucose monitoring (CGM) a useful management tool. We evaluated the accuracy of the Dexcom G6 CGM in pediatric intensive care unit patients following TPIAT. Twenty-five patients who underwent TPIAT had Dexcom G6 glucose values compared to paired serum glucose values. All paired glucose samples were obtained within 5 minutes of each other during the first seven days post TPIAT. Data were evaluated using mean absolute difference (MAD), mean absolute relative difference (MARD), %20/20, %15/15 accuracy, and Clarke Error Grid analysis. Exclusions included analysis during the CGM “warm-up” period and hydroxyurea administration (known drug interference). A total of 183 time-matched samples were reviewed during postoperative days 2–7. MAD was 14.7 mg/dL and MARD was 13.4%, with values of 15.2%, 14.0%, 12.1%, 11.4%, 13.2% and 14.1% at days 2, 3, 4, 5, 6 and 7, respectively. Dexcom G6 had a %20/20 accuracy of 78%, and a %15/15 accuracy of 64%. Clarke Error Grid analysis showed that 77% of time-matched values were clinically accurate, and 100% were clinically acceptable. The Dexcom G6 CGM may be an accurate tool producing clinically acceptable values to make reliable clinical decisions in the immediate post-TPIAT period. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)
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Review

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20 pages, 345 KiB  
Review
Total Pancreatectomy with Autologous Islet Cell Transplantation—The Current Indications
by Beata Jabłońska and Sławomir Mrowiec
J. Clin. Med. 2021, 10(12), 2723; https://doi.org/10.3390/jcm10122723 - 20 Jun 2021
Cited by 10 | Viewed by 3337
Abstract
Total pancreatectomy is a major complex surgical procedure involving removal of the whole pancreatic parenchyma and duodenum. It leads to lifelong pancreatic exocrine and endocrine insufficiency. The control of surgery-induced diabetes (type 3) requires insulin therapy. Total pancreatectomy with autologous islet transplantation (TPAIT) [...] Read more.
Total pancreatectomy is a major complex surgical procedure involving removal of the whole pancreatic parenchyma and duodenum. It leads to lifelong pancreatic exocrine and endocrine insufficiency. The control of surgery-induced diabetes (type 3) requires insulin therapy. Total pancreatectomy with autologous islet transplantation (TPAIT) is performed in order to prevent postoperative diabetes and its serious complications. It is very important whether it is safe and beneficial for patients in terms of postoperative morbidity and mortality, and long-term results including quality of life. Small duct painful chronic pancreatitis (CP) is a primary indication for TPAIT, but currently the indications for this procedure have been extended. They also include hereditary/genetic pancreatitis (HGP), as well as less frequent indications such as benign/borderline pancreatic tumors (intraductal papillary neoplasms, neuroendocrine neoplasms) and “high-risk pancreatic stump”. The use of TPAIT in malignant pancreatic and peripancreatic neoplasms has been reported in the worldwide literature but currently is not a standard but rather a controversial management in these patients. In this review, history, technique, indications, and contraindications, as well as short-term and long-term results of TPAIT, including pediatric patients, are described. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)
8 pages, 212 KiB  
Review
What Is New with Total Pancreatectomy and Autologous Islet Cell Transplantation? Review of Current Progress in the Field
by Xavier L. Baldwin, Brittney M. Williams, Beth Schrope and Chirag S. Desai
J. Clin. Med. 2021, 10(10), 2123; https://doi.org/10.3390/jcm10102123 - 14 May 2021
Cited by 6 | Viewed by 2433
Abstract
Patients with chronic pancreatitis have benefited from total pancreatectomy and autologous islet cell transplantation (TPAIT) since the 1970s. Over the past few decades, improvements have been made in surgical technique and perioperative management that have led to improved success of islet cell function, [...] Read more.
Patients with chronic pancreatitis have benefited from total pancreatectomy and autologous islet cell transplantation (TPAIT) since the 1970s. Over the past few decades, improvements have been made in surgical technique and perioperative management that have led to improved success of islet cell function, insulin independence and patient survival. This article focuses on recent updates and advances for the TPAIT procedure that continue to expand and innovate the impact on patients with debilitating disease. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)

Other

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7 pages, 1314 KiB  
Commentary
Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting
by Piotr Witkowski, Jon Odorico, Jordan Pyda, Roi Anteby, Robert J. Stratta, Beth A. Schrope, Mark A. Hardy, John Buse, Joseph R. Leventhal, Wanxing Cui, Shakir Hussein, Silke Niederhaus, Jason Gaglia, Chirag S. Desai, Martin Wijkstrom, Fouad Kandeel, Piotr J. Bachul, Yolanda Tai Becker, Ling-Jia Wang, R. Paul Robertson, Oyedolamu K. Olaitan, Tomasz Kozlowski, Peter L. Abrams, Michelle A. Josephson, Kenneth A. Andreoni, Robert C. Harland, Raja Kandaswamy, Andrew M. Posselt, Gregory L. Szot, Camillo Ricordi and on behalf of the Islets for US Collaborativeadd Show full author list remove Hide full author list
J. Clin. Med. 2021, 10(13), 2878; https://doi.org/10.3390/jcm10132878 - 29 Jun 2021
Cited by 5 | Viewed by 2854
Abstract
The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has [...] Read more.
The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has stalled the development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA’s position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the “Islets for US Collaborative” designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system. Full article
(This article belongs to the Special Issue Islet Cell Transplantation for Treatment of Pancreatic Diseases)
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