Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience
| Autor: | Karen Prater, Sara Richman, Timothy D. Henry, Jeannette Bloom, Adrian P. Gee, Christopher R. Cogle, David H. McKenna, Carl J. Pepine, Lemuel A. Moyé, Jane Reese Koç, Steven Ellis, Doris A. Taylor, Jay H. Traverse, David Zhao, James T. Willerson, Diann Fisk, April G. Durett, Robert D. Simari, Sonia I. Skarlatos |
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| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Quality Control
Cancer Research medicine.medical_specialty Laboratory Proficiency Testing Cell processing Immunology Cell Culture Techniques Cell- and Tissue-Based Therapy Myocardial Infarction Cell Count Cell Separation Validation Studies as Topic Regenerative Medicine Regenerative medicine Article Cardiovascular Cell Therapy Research Network Bone Marrow medicine Immunology and Allergy Humans Medical physics Clinical treatment Genetics (clinical) Automation Laboratory Transplantation business.industry Mesenchymal Stem Cells Cell Biology Autologous bone Flow Cytometry Clinical trial Oncology Practice Guidelines as Topic business |
| Popis: | Background aims. Multicenter cellular therapy clinical trials require the establishment and implementation of standardized cell-processing protocols and associated quality control (QC) mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods. Standardized cell preparations, consisting of autologous bone marrow (BM) mononuclear cells, prepared using a Sepax device, were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central QC program that included product evaluation by the CCTRN biorepositories. Results. Data from the first 60 procedures demonstrated that uniform products, that met all release criteria, could be manufactured at all five sites within 7 h of receipt of BM. Uniformity was facilitated by use of automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized QC. Conclusions. Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training and QC. |
| Databáze: | OpenAIRE |
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