Factors affecting the turnaround time for manufacturing, testing, and release of cellular therapy products prepared at multiple sites in support of multicenter cardiovascular regenerative medicine protocols: a Cardiovascular Cell Therapy Research Network (CCTRN) study. Transfusion 2012 Oct;52(10):2225-33
Date
02/11/2012Pubmed ID
22320233Pubmed Central ID
PMC3355200DOI
10.1111/j.1537-2995.2011.03543.xScopus ID
2-s2.0-84868301700 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
BACKGROUND: Cellular therapy studies are often conducted at multiple clinical sites to accrue larger patient numbers. In many cases this necessitates use of localized good manufacturing practices facilities to supply the cells. To assure consistent quality, oversight by a quality assurance group is advisable. In this study we report the findings of such a group established as part of the Cardiovascular Cell Therapy Research Network (CCTRN) studies involving use of autologous bone marrow mononuclear cells (ABMMCs) to treat myocardial infarction and heart failure.
STUDY DESIGN AND METHODS: Factors affecting cell manufacturing time were studied in 269 patients enrolled on three CCTRN protocols using automated cell processing system (Sepax, Biosafe SA)-separated ABMMCs. The cells were prepared at five good manufacturing practices cell processing facilities and delivered to local treatment sites or more distant satellite centers.
RESULTS: Although the Sepax procedure takes only 90 minutes, the total time for processing was approximately 7 hours. Contributing to this were incoming testing and device preparation, release testing, patient randomization, and product delivery. The mean out-of-body time (OBT), which was to be less than 12 hours, averaged 9 hours. A detailed analysis of practices at each center revealed a variety of factors that contributed to this OBT.
CONCLUSION: We conclude that rapid cell enrichment procedures may give a false impression of the time actually required to prepare a cellular therapy product for release and administration. Institutional procedures also differ and can contribute to delays; however, in aggregate it is possible to achieve an overall manufacturing and testing time that is similar at multiple facilities.
Author List
Richman S, Gee AP, McKenna DH, Traverse JH, Henry TD, Fisk D, Pepine CJ, Bloom J, Willerson JT, Prater K, Zhao D, Koç JR, Anwaruddin S, Taylor DA, Cogle CR, Moyé LA, Simari RD, Skarlatos SIAuthor
Saif Anwaruddin MD Associate Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AutomationBone Marrow Cells
Bone Marrow Transplantation
Cell Separation
Cell Survival
Clinical Trials, Phase II as Topic
Colony-Forming Units Assay
Consumer Product Safety
Cryopreservation
Double-Blind Method
Humans
Myocardial Infarction
Preservation, Biological
Quality Assurance, Health Care
Randomized Controlled Trials as Topic
Regenerative Medicine
Time Factors
Tissue and Organ Harvesting
Transportation
