ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2021
The demise of islet allotransplantation in the United States: A call for an urgent regulatory update.
Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed.
- Trial
- Cell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Review
- Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- The future of islet transplantation beyond the BLA approval: challenges and opportunities.Frontiers in transplantation · 2025Review
- Demise of cadaveric islet transplantation in the USA: Quo Vadis, 1 year after BLA approval and 24 years after the Edmonton breakthrough?Frontiers in transplantation · 2025Review
- From Edmonton to Lantidra and beyond: immunoengineering islet transplantation to cure type 1 diabetes.Frontiers in transplantation · 2025Review
- An analysis of the UK national pancreas allocation scheme.Frontiers in transplantation · 2024Article
- The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024Article
- Regulatory approval of islet transplantation for treatment of type 1 diabetes: Implications and what is on the horizon.Molecular therapy : the journal of the American Society of Gene Therapy · 2023Article
- Type 1 diabetes and engineering enhanced islet transplantation.Advanced drug delivery reviews · 2022Review
- A Worldwide Survey of Activities and Practices in Clinical Islet of Langerhans Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Pain resolution and glucose control in pediatric patients with chronic pancreatitis after total pancreatectomy with islet auto-transplantation.Pediatric surgery international · 2021Article
- 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.Journal of clinical medicine · 2021Article
- Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.Frontiers in endocrinology · 2021Article
- Why pancreatic islets should be regarded and regulated like organs.CellR4-- repair, replacement, regeneration, & reprogramming · 2021Article
- Towards a Rational Balanced Pancreatic and Islet Allocation Schema.Cell transplantationArticle
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Authors and funding
46 authors.
Funding
Abstract
Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and "more than minimally manipulated" human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as "minimally manipulated tissue" and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.