Regulatory considerations of delayed autologous islet infusion in a 4-year-old child undergoing total pancreatectomy for chronic pancreatitis

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Abstract

In patients undergoing total pancreatectomy for chronic pancreatitis, isolation, and infusion of autologous islets must comply with Good Manufacturing Practices standards established by the Food and Drug Administration (FDA) but does not standardly require an Investigational New Drug (IND) status. We report a case of a 4-year-old child with severe hereditary pancreatitis who developed clinical sepsis during total pancreatectomy (TP) surgery; subsequent pancreas, islet, and blood cultures were positive for Enterococcus. Because of clinical deterioration, planned islet infusion was aborted and islets were kept viable in a culture period while the patient was stabilized. Two days later, 38 000 islet equivalents (IEQ, 2808 IEQ/kg) were infused in a second procedure. Because maintaining the islets in culture met the FDA standard for “more than minimal” tissue manipulation, an emergency IND was obtained from the FDA to permit delayed infusion. The patient tolerated islet infusion well, and subsequently has partial islet graft function with normal glucoses and minimal insulin needs. This case highlights the possibility to delay islet infusion in an emergency, the potential for success with few islets in a young child, and the need to consider regulatory complexities of islet transplant in this situation.

Original languageEnglish (US)
Pages (from-to)306-310
Number of pages5
JournalAmerican Journal of Transplantation
Volume20
Issue number1
DOIs
StatePublished - Jan 1 2020

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Keywords

  • clinical research/practice
  • islet isolation
  • islet transplantation
  • patient survival
  • pediatrics

PubMed: MeSH publication types

  • Case Reports

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