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

作者：Gee Adrian P^*; Richman Sara; Durett April; McKenna David; Traverse Jay; Henry Timothy; Fisk Diann; Pepine Carl; Bloom Jeannette; Willerson James; Prater Karen; Zhao David; Koc Jane Reese; Ellis Steven; Taylor Doris; Cogle Christopher; Moye Lemuel; Simari Robert; Skarlatos Sonia

来源：Cytotherapy, 2010, 12(5): 684-691.

DOI：10.3109/14653249.2010.487900

• cardiac cell therapy
• cell therapy
• multicenter trials
• quality control
• regenerative medicine
• Sepax

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.

• 出版日期2010