Concise Review: Manufacturing of Pancreatic Endoderm Cells for Clinical Trials in Type 1 Diabetes
| Autor: | Thomas C. Schulz |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Blood Glucose
medicine.medical_specialty Cellular differentiation Population Biology In vivo Insulin-Secreting Cells Internal medicine medicine Humans Enabling Technologies for Cell-Based Clinical Translation education Pancreas Embryonic Stem Cells Clinical Trials as Topic education.field_of_study Type 1 diabetes Cell Differentiation Cell Biology General Medicine medicine.disease Embryonic stem cell Cell biology Transplantation Diabetes Mellitus Type 1 medicine.anatomical_structure Endocrinology Endoderm Developmental Biology |
| Zdroj: | Stem Cells Translational Medicine. 4:927-931 |
| ISSN: | 2157-6580 2157-6564 |
| Popis: | The cellular component of ViaCyte's VC-01 combination product for type 1 diabetes, pancreatic endoderm cells (PEC-01) derived from CyT49 human embryonic stem cells, matures after transplantation and functions to regulate blood glucose in rodent models. The aims in manufacturing PEC-01 at scale are to generate a consistent and robust transplantable population that functions reliably and safely in vivo. ViaCyte has integrated multiple bioprocessing strategies to enable a tightly controlled PEC-01 manufacturing process for clinical entry. Significance This review summarizes the manufacturing process for the first human embryonic stem cell-based candidate treatment for type 1 diabetes to enter clinical testing. It presents the key strategic principles used to enable scaled production of pancreatic endoderm and will have widespread interest in academia and biopharma. |
| Databáze: | OpenAIRE |
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