Effects of interruptions of controlled‐rate freezing on the viability of umbilical cord blood stem cells

Yang, Hang; Pidgorna, Alla; Loutfy, Mona; Shuen, Paul

doi:10.1111/trf.12774

Cited by 11 publications

(7 citation statements)

References 27 publications

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“…In this study the number of viable CD34 + cells was not significantly reduced under any of the conditions tested, but CFU-GM were specifically and significantly lower if cryopreservation using a CRF was interrupted at different temperature points and cells transferred directly to LNVP (usually below À150°C) if the cells had not reached a sufficiently low temperature (À40°C) before the transfer. In contrast, no significant differences were seen in CFU-GM or CD34 + cell viability in paired samples transferred to a À80°C mechanical freezer from the CRF at any temperature point (Yang et al, 2015).…”

Section: Discussionmentioning

confidence: 76%

“…In particular, cooling after the transition phase greater than 5-6°C/min has been reported to be associated with CFU-GM loss and delayed re-engraftment after reinfusion into patients (Abrams et al, 1980;Gorin et al, 1983). In contrast, no significant differences were seen in CFU-GM or CD34 + cell viability in paired samples transferred to a À80°C mechanical freezer from the CRF at any temperature point (Yang et al, 2015). The CRF programme in use at GOSH since the early 1990s was established when bone marrow was the exclusive stem cell source at the time of these early reports and it is possible that the more recent use of PBSC could be a factor A recent study using umbilical cord blood (UCB) confirms the negative impact of excessively rapid cooling and may be relevant to the clinical incident as an example of major CFU-GM activity loss without comparable CD34 + cell death related to rapid freezing conditions.…”

Section: Discussionmentioning

confidence: 99%

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Post‐thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes

et al. 2016

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Standard quality assurance (QA) of cryopreserved peripheral blood stem cells (PBSC) uses post-thaw viable CD34(+) cell counts. In 2013, concerns arose at Great Ormond Street Hospital (GOSH) about 8 patients with delayed engraftment following myeloablative chemotherapy with cryopreserved cell rescue, despite adequate post-thaw viable cell counts in all cases. Root cause analysis was undertaken; investigations suggested the freeze process itself was a contributing factor to suboptimal engraftment. Experiments were undertaken in which a single PBSC product was divided into three and cryopreserved in parallel using a control-rate freezer (CRF) or passive freezing method (-80°C freezer) at GOSH, or the same passive freezing at another laboratory. Viable CD34(+) counts were equivalent and adequate in each. Granulocyte-monocyte colony-forming unit assays demonstrated colonies from the products cryopreserved using passive freezing (both laboratories), but no colonies from products cryopreserved using the CRF. The CRF was shown to be operating within manufacturer's specifications with freeze-profile within acceptable limits. This experience has important implications for quality assurance for all transplant programmes, particularly those using cryopreserved products. The failure of post-thaw viable CD34(+) counts, the most widely used routine QA test available, to ensure PBSC function is of great concern and should prompt reassessment of protocols and QA procedures.

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Post‐thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes

et al. 2016

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“…Although rare, malfunction or failure of the controlled-rate freezing device is a potential risk. One interesting study examined the effects of interruptions of controlled-rate freezing on the viability of umbilical cord cells in order to provide guidance of the proper response in case of freezing device failure [76]. There was no difference in post-thaw survival between the temperature at which cooling was interrupted if cells were transferred to a –80°C freezer; however, cells should only be transferred to vapor nitrogen when the interrupting temperature was lower than –40°C.…”

Section: Additional Considerationsmentioning

confidence: 99%

Cryopreservation of Hematopoietic Stem Cells: Emerging Assays, Cryoprotectant Agents, and Technology to Improve Outcomes

Hornberger

McKenna

et al. 2019

Transfus Med Hemother

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Hematopoietic stem cell (HSC) therapy is widely used to treat a growing number of hematological and non-hematological diseases. Cryopreservation of HSCs allows for cells to be transported from the site of processing to the site of clinical use, creates a larger window of time in which cells can be administered to patients, and allows sufficient time for quality control and regulatory testing. Currently, HSCs and other cell therapies conform to the same cryopreservation techniques as cells used for research purposes: cells are cryopreserved in dimethyl sulfoxide (DMSO) at a slow cooling rate. As a result, HSC therapy can result in numerous adverse symptoms in patients due to the infusion of DMSO. Efforts are being made to improve the cryopreservation of HSCs for clinical use. This review discusses advances in the cryopreservation of HSCs from 2007 to the present. The preclinical development of new cryoprotectants and new technology to eliminate cryoprotectants after thawing are discussed in detail. Additional cryopreservation considerations are included, such as cooling rate, storage temperature, and cell concentration. Preclinical cell assessment and quality control are discussed, as well as clinical studies from the past decade that focus on new cryopreservation protocols to improve patient outcomes.

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“…Interestingly, Yang et al () explored the rapid post freeze cooling of cord blood samples to ascertain the outcome of transferring frozen cells directly in vapour phase liquid nitrogen should a programmable rate freezer break down at any time. Rapid post‐freeze cooling was deleterious to GM‐CFC recovery unless the cells were already at −40°C or below at the time of transfer to vapour phase nitrogen.…”

Section: Cryoprotectant and Cryopreservation Cooling Curvesmentioning

confidence: 99%

Optimisation and quality control of cell processing for autologous stem cell transplantation

Watts

Linch

2016

Br J Haematol

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Clinical practice and the technology of cell processing for autologous stem cell transplantation has continued to evolve over the last two decades and merits review of current quality control expectations. The external regulatory era has improved quality and safety standards but there is still variable practice, with specific risks illuminated by a number of clinical incidents. Viable CD34 cell assays may fail to indicate significant losses in progenitor function during storage, particularly after cryopreservation, and there is a need to develop an alternative, real time functional assay to replace colony assays. The ultimate guide to potency and successful cell processing for haematopoietic progenitor cell products is prompt and reproducible engraftment and close monitoring is essential for safety and quality control.

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Effects of interruptions of controlled‐rate freezing on the viability of umbilical cord blood stem cells

Cited by 11 publications

References 27 publications

Post‐thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes

Post‐thaw viability of cryopreserved peripheral blood stem cells (PBSC) does not guarantee functional activity: important implications for quality assurance of stem cell transplant programmes

Cryopreservation of Hematopoietic Stem Cells: Emerging Assays, Cryoprotectant Agents, and Technology to Improve Outcomes

Optimisation and quality control of cell processing for autologous stem cell transplantation

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