Background aims The Quantum® Cell Expansion System (Quantum; Terumo BCT, Inc, Lakewood, CO, USA) is a novel hollow fiber-based device that automates and closes the cell culture process, reducing labor intensive tasks such as manual cell culture feeding and harvesting. The manual cell selection and expansion processes for the production of clinical-scale quantities of bone marrow-derived human mesenchymal stromal cells (BM-hMSCs) have been successfully translated onto the Quantum platform previously. The formerly static, manual, in vitro process performed primarily on tissue culture polystyrene substrates may raise the question of whether BM-hMSCs cultured on a hollow fiber platform yields comparable cell quality. Methods A rigorous battery of assays was used to determine the genetic stability of BM-hMSCs selected and produced with the Quantum. In this study, genetic stability was determined by assessing spectral karyotype, micronucleus formation and tumorigenicity to resolve chromosomal aberrations in the stem cell population. Cell phenotype, adherent growth kinetics and tri-lineage differentiation were also evaluated. HMSC bone marrow aspirates, obtained from three approved donors, were expanded in parallel using T225 culture flasks and the Quantum. Results BM-hMSCs harvested from the Quantum demonstrated immunophenotype, morphology and tri-lineage differentiation capacity characteristics consistent with the International Society of Cell Therapy standard for hMSCs. Cell populations showed no malignant neoplastic formation in athymic mice 60 days post-transplant, no clonal chromosomal aberrations were observed and no DNA damage was found as measured by micronucleus formation. Conclusions Quantum-produced BM-hMSCs are of comparable quality and demonstrate analogous genetic stability to BM-hMSCs cultured on tissue culture polystyrene substrates.

Background There are challenges related to the accurate and efficient measurement of lymphedema in people with breast cancer. The LymphaTech 3D Imaging System (LymphaTech, Atlanta, GA, USA) is a mobile, noninvasive platform that provides limb geometry measurements. Objective The objective of this study was to estimate the reliability and validity of the LymphaTech for measuring arm volume in the context of women seeking care in a specialty breast cancer rehabilitation clinic. Design This was a cross-sectional reliability and convergent validity study. Methods People who had stage I to IV breast cancer with lymphedema or were at risk for it were included. Arm volume was measured in 66 participants using the LymphaTech and perometer methods. Test-retest reliability for a single measure, limb volume difference, and agreement between methods was analyzed for 30 participants. A method-comparison analysis was also used to assess convergent validity between methods. Results Both LymphaTech and perometer methods displayed intraclass correlation coefficients (ICCs) of ≥0.99. The standard errors of measurement for the LymphaTech and length-matched perometer measurements were nearly identical. Similar intraclass correlation coefficients (0.97) and standard errors of measurement (38.0–40.7 mL) were obtained for the between-limb volume difference for both methods. The convergent validity analyses demonstrated no systematic difference between methods. Limitations The sample size was not based on a formal sample size calculation. LymphaTech measurements included interrater variance, and perometer measurements contained intrarater variance. Conclusions The LymphaTech had excellent test-retest reliability, and convergent validity was supported. This technology is efficient and portable and has a potential role in prospective surveillance and management of lymphedema in clinical, research, and home settings.

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