Microbial pathogens of hematopoietic stem cells – screening and testing for infectious diseases

Reich-Slotky, Ronit; Semidei-Pomales, Mildred; Schwartz, Joseph

doi:10.1097/mrm.0b013e3282cdf04a

Cited by 3 publications

(4 citation statements)

References 64 publications

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“…Personnel of donation, collection, or transplantation centers, cell-processing laboratories, and courier services should follow current standards for detecting and preventing extrinsic bacterial and fungal contamination of collected stem cell units at the collection site, during processing and transportation, and at the transplant center 126 , 127 , 128 , 129 , 130 , 131 , 132 , 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 . Current, comprehensive discussions of these issues are detailed in the Food and Drug Administration (FDA) “Good Tissue Practice” regulations [142] , in the European Commission regulations [81] , and in international standards established by the professional organizations 76 , 77 , 143 .…”

Section: Hematopoietic Cell Graft Safetymentioning

confidence: 99%

Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients: A Global Perspective

Tomblyn¹,

Chiller²,

Einsele³

et al. 2009

Biology of Blood and Marrow Transplantation

1,571

1,540

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Section: Hematopoietic Cell Graft Safetymentioning

confidence: 99%

Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients: A Global Perspective

Tomblyn¹,

Chiller²,

Einsele³

et al. 2009

Biology of Blood and Marrow Transplantation

1,571

1,540

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“…Sterile filtration is not applicable due to the smaller mean diameters of bacteria in comparison with those of eukaryotic cells. Heat treatment such as autoclaving, radioactive irradiation and chemical treatment by ethylene dioxide or pathogen reduction procedures will damage or destroy the cellular elements of the product . Bacteria, as a rule, are not killed by deep freezing since plasma proteins serve as cryoprotectants, and thus, they are conserved in living state.…”

Section: Problems In Bacterial Safety Of Hpcsmentioning

confidence: 99%

“…Borrelia recurrentis , Anaplasma phagocytophilum, Coxiella burnetii , Bartonella species ) and parasites (e.g. Trypanosoma cruci , Plasmodium or Babesia species ) are not cultivable in the usual microbiological media and, therefore, will not be detected in microbiological control testing procedures .…”

Section: Problems In Bacterial Safety Of Hpcsmentioning

confidence: 99%

“…In contrast, problems regarding bacterial safety of cell therapeutics belonging to the advanced therapy medicinal products (ATMPs) are at best only partially solved. Many of the current established procedures for ready‐for‐use biologicals cannot be applied to these components in the same manner . Sterility of source materials cannot be guaranteed, and the so far known procedures for sterilization are, as a rule, not feasible.…”

Section: Introductionmentioning

confidence: 99%

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Bacterial safety of cell‐based therapeutic preparations, focusing on haematopoietic progenitor cells

et al. 2013

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Bacterial safety of cellular preparations, especially haematopoietic progenitor cells (HPCs), as well as advanced therapy medicinal products (ATMPs) derived from stem cells of various origins, present a challenge for physicians, manufacturers and regulators. The article describes the background and practical issues in this area and illustrates why sterility of these products cannot currently be guaranteed. Advantages and limitations of approaches both for classical sterility testing and for microbiological control using automated culture systems are discussed. The review considers novel approaches for growth-based rapid microbiological control with high sensitivity and faster availability of results, as well as new methods for rapid bacterial detection in cellular preparations enabling meaningful information about product contamination within one to two hours. Generally, however, these direct rapid methods are less sensitive and have greater sampling error compared with the growth-based methods. Opportunities for pyrogen testing of cell therapeutics are also discussed. There is an urgent need for development of novel principles and methods applicable to bacterial safety of cellular therapeutics. We also need a major shift in approach from the traditional view of sterility evaluation (identify anything and everything) to a new thinking about how to find what is clinically relevant within the time frame available for the special clinical circumstances in which these products are used. The review concludes with recommendations for optimization of microbiological control of cellular preparations, focusing on HPCs.

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2009

Bone Marrow Transplant

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Microbial pathogens of hematopoietic stem cells – screening and testing for infectious diseases

Cited by 3 publications

References 64 publications

Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients: A Global Perspective

Guidelines for Preventing Infectious Complications among Hematopoietic Cell Transplantation Recipients: A Global Perspective

Bacterial safety of cell‐based therapeutic preparations, focusing on haematopoietic progenitor cells

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