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.

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.

A simulation-based curriculum can be used to teach open intestinal anastomosis.

BACKGROUND: Simulation is a technique commonly used to teach technical skills such as those necessary in laparoscopic surgery. Curricula with objective, validated metrics rating performance are widely used. Simulations to develop and assess skills necessary for open surgical procedures are less common. We hypothesized that a curriculum designed to teach the skills necessary to perform open laparotomy and bowel anastomosis would result in improved knowledge of the procedure steps, increased technical skills, and improved confidence in novice surgeons. METHODS: A simulation-based curriculum designed to teach open laparotomy and bowel anastomosis was developed. Eleven surgical interns participated in the 6-wk curriculum. Written surveys regarding confidence in the knowledge and ability to perform these procedures were administered before and after the curriculum. Videos of the first six subjects were created on the first and final repetition of the simulation. An Objective Assessment of Technical Skills (OSATS) instrument was used to evaluate each video by two independent, blinded reviewers. RESULTS: Subjects demonstrated significantly improved OSATS scores for skills and knowledge in seven of nine domains assessed upon completion of the curriculum. Subject confidence in laparotomy and bowel anastomosis skills improved significantly. CONCLUSION: A structured, simulation-based curriculum designed to teach laparotomy and hand-sewn bowel anastomosis skills is effective and increases participant confidence. Further study is required to determine whether simulation results in improved performance in the operating room.

Pancreas surgical complications.

PURPOSE OF REVIEW: Whole organ pancreas transplantation is the most durable cure for type 1 diabetes. Many advances have occurred that allow for long-term freedom from insulin and abrogation of the secondary complications of diabetes. However, pancreas allograft survival is dependant upon excellent technical success in the first month following transplantation. RECENT FINDINGS: It is clear that prevention of surgical complications has implications not only for graft and patient survival but also significantly impacts the financial impact following transplantation. Although complications can occur, early appropriate management can limit morbidity. In addition, when pancreas and kidney transplantation occur simultaneously, delayed treatment of pancreas complications can lead to kidney allograft loss. SUMMARY: This review concentrates on the diagnosis and management of early surgical complications following pancreas transplantation. The financial implications of surgical outcomes in pancreas transplantation are also discussed.

Sudden late onset of gross hematuria in a previous renal transplant recipient 3 months after transplant nephrectomy.

Causes of gross hematuria in a patient with end-stage renal disease are limited compared with those in patients with normal renal function. Given the increased likelihood of patients with end-stage renal disease developing renal cell carcinoma, the workup focuses on a careful evaluation of the collecting system. The workup for gross hematuria in a renal transplant recipient is similar; however, the focus shifts toward a more thorough evaluation of the transplanted kidney and bladder because immunosuppression increases the overall risk for malignancy. An immunosuppressed patient also is at risk for infectious processes in the transplanted kidney manifesting as gross hematuria. Concerns for chronic rejection also should be investigated, although microscopic hematuria is more common in this scenario. If this is unrevealing, then close scrutiny of the native kidneys for possible sources of bleeding is warranted. We present an interesting and unusual cause of painless gross hematuria in a patient with end-stage renal disease and transplant nephrectomy 3 months before the onset of bleeding.