Trial reportDiabetes2016
National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.
Trial report in Diabetes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00434811 (Islet Transplantation in Type 1 Diabetes), which is not on this map. Cited by 107 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Islet Transplantation in Type 1 Diabetes
Who cites it
107 citing papers in PubMed, 1 synthesis or guideline pooled it, 193 citations in OpenAlex.
- Pooled it
- α- or β-Adrenergic blockade does not affect transplanted islet cell responses to hypoglycemia in type 1 diabetes.American journal of physiology. Endocrinology and metabolism · 2024Trial
- Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021Trial
- Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.Diabetes care · 2018Trial
- Trial
- Zinc accumulation-induced integrated stress response triggers β-cell identity loss.Cell research · 2026Article
- Donation After Circulatory Death Islets are Comparable to Standard-of-Care Donation After Brain Death Islets: Analysis of 801 Consecutive Human Islet Isolations.Transplantation direct · 2026Article
- Peptide hormone spexin restores beta cell function and improves glycaemic control in mice via regulation of the sodium-potassium pump.Diabetologia · 2026Article
- Immune modulation for β-cell replacement in type 1 diabetes.Frontiers in immunology · 2026Review
- Towards curing type 1 diabetes: Prospects and challenges of allogeneic or xenogeneic donor islet cell transplantation.World journal of transplantation · 2025Review
- The Heterogeneity of Type 1 Diabetes: Implications for Pathogenesis, Prevention, and Treatment-2024 Diabetes, Diabetes Care, and Diabetologia Expert Forum.Diabetes care · 2025Review
- Review
- Islet dimension and its impact on transplant outcome: A systematic review.World journal of transplantation · 2025Article
- The heterogeneity of type 1 diabetes: implications for pathogenesis, prevention, and treatment-2024 Diabetes, Diabetes Care, and Diabetologia Expert Forum.Diabetologia · 2025Review
- A continuously oxygenated macroencapsulation system enables high-density packing and delivery of insulin-secreting cells.Nature communications · 2025Article
- Article
- Advances in Cell Replacement Therapies for Diabetes.Diabetes · 2025Review
- Cell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Review
- A Compound Screen Based on Isogenic hESC-Derived β Cell Reveals an Inhibitor Targeting ZnT8-Mediated Zinc Transportation to Protect Pancreatic β Cell from Stress-Induced Cell Death.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
47 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
36 authors at 12 institutions in 3 countries.
Funding
Abstract
Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.