Multicenter cell processing for cardiovascular regenerative medicine applications: The Cardiovascular Cell Therapy Research Network (CCTRN) experience

Adrian P. Gee, Sara Richman, April Durett, David McKenna, Jay Traverse, Timothy Henry, Diann Fisk, Carl Pepine, Jeannette Bloom, James Willerson, Karen Prater, David Zhao, Jane Reese Koç, Steven Ellis, Doris Taylor, Christopher Cogle, Lemuel Moyé, Robert Simari, Sonia Skarlatos

Research output: Contribution to journalArticle

24 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)684-691
Number of pages8
JournalCytotherapy
Volume12
Issue number5
DOIs
StatePublished - Sep 2010

Keywords

  • Cardiac cell therapy
  • Cell therapy
  • Multicenter trials
  • Quality control
  • Regenerative medicine
  • Sepax

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Oncology
  • Genetics(clinical)
  • Cell Biology
  • Cancer Research
  • Transplantation

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  • Cite this

    Gee, A. P., Richman, S., Durett, A., McKenna, D., Traverse, J., Henry, T., Fisk, D., Pepine, C., Bloom, J., Willerson, J., Prater, K., Zhao, D., Koç, J. R., Ellis, S., Taylor, D., Cogle, C., Moyé, L., Simari, R., & Skarlatos, S. (2010). Multicenter cell processing for cardiovascular regenerative medicine applications: The Cardiovascular Cell Therapy Research Network (CCTRN) experience. Cytotherapy, 12(5), 684-691. https://doi.org/10.3109/14653249.2010.487900