National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities
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- Camillo Ricordi
- Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL
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- Julia S. Goldstein
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
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- A.N. Balamurugan
- Schulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, MN
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- Gregory L. Szot
- Department of Surgery, University of California, San Francisco, San Francisco, CA
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- Tatsuya Kin
- Clinical Islet Transplant Program and Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
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- Chengyang Liu
- Institute for Diabetes, Obesity and Metabolism and Departments of Surgery and Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
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- Christine W. Czarniecki
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
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- Barbara Barbaro
- Division of Transplantation, University of Illinois Hospital and Health Sciences System, Chicago, IL
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- Nancy D. Bridges
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD
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- Jose Cano
- Division of Transplantation, Department of Surgery, Emory Transplant Center, Emory University, Atlanta, GA
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- William R. Clarke
- Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA
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- Thomas L. Eggerman
- National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD
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- Lawrence G. Hunsicker
- Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA
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- Dixon B. Kaufman
- Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
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- Aisha Khan
- Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL
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- David-Erick Lafontant
- Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA
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- Elina Linetsky
- Diabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL
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- Xunrong Luo
- Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
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- James F. Markmann
- Division of Transplant Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA
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- Ali Naji
- Institute for Diabetes, Obesity and Metabolism and Departments of Surgery and Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
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- Olle Korsgren
- Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden
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- Jose Oberholzer
- Division of Transplantation, University of Illinois Hospital and Health Sciences System, Chicago, IL
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- Nicole A. Turgeon
- Division of Transplantation, Department of Surgery, Emory Transplant Center, Emory University, Atlanta, GA
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- Daniel Brandhorst
- Department of Clinical Immunology, Rudbeck Laboratory, Uppsala University, Uppsala, Sweden
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- Xiaojuan Chen
- Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
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- Andrew S. Friberg
- Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden
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- Ji Lei
- Division of Transplant Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA
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- Ling-jia Wang
- Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
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- Joshua J. Wilhelm
- Schulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, MN
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- Jamie Willits
- Clinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, IA
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- Xiaomin Zhang
- Comprehensive Transplant Center, Northwestern University Feinberg School of Medicine, Chicago, IL
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- Bernhard J. Hering
- Schulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, MN
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- Andrew M. Posselt
- Department of Surgery, University of California, San Francisco, San Francisco, CA
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- Peter G. Stock
- Department of Surgery, University of California, San Francisco, San Francisco, CA
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- A.M. James Shapiro
- Clinical Islet Transplant Program and Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada
説明
<jats:p>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.</jats:p>
収録刊行物
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- Diabetes
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Diabetes 65 (11), 3418-3428, 2016-07-27
American Diabetes Association
