Evaluation of the effectiveness of a new cryopreservation system based on a two-compartment vial for the cryopreservation of cell therapy products.

BACKGROUND AIMS: Successful cell cryopreservation and banking remain a major challenge for the manufacture of cell therapy products, particularly in relation to providing a hermetic, sterile cryovial that ensures optimal viability and stability post-thaw while minimizing exposure to toxic cryoprotective agents, typically dimethyl sulfoxide (Me2SO). METHODS: In the present study, the authors evaluated the effectiveness and functionality of Limbo technology (Cellulis S.L., Santoña, Spain). This system provides a hermetic vial with two compartments (one for adding cells with the cryoprotective agent solution and the other for the diluent solution) and an automated defrosting device. Limbo technology (Cellulis S.L.) allows reduction of the final amount of Me2SO, sidestepping washing and dilution steps and favoring standardization. The study was performed in several Good Manufacturing Practice laboratories manufacturing diverse cell therapy products (human mesenchymal stromal cells, hematopoietic progenitor cells, leukapheresis products, fibroblasts and induced pluripotent stem cells). Laboratories compared Limbo technology (Cellulis S.L.) with their standard cryopreservation procedure, analyzing cell recovery, viability, phenotype and functionality. RESULTS: Limbo technology (Cellulis S.L.) maintained the viability and functionality of most of the cell products and preserved sterility while reducing the final concentration of Me2SO. CONCLUSIONS: Results showed that use of Limbo technology (Cellulis S.L.) offers an overall safe alternative for cell banking and direct infusion of cryopreserved cell products into patients.

[Clinical and laboratorial predictors related to progression to chronic kidney disease in patients with autosomal dominant polycystic kidney disease]. / Factores clínicos y de laboratorio relacionados con progresión a enfermedad renal crónica en pacientes con enfermedad renal poliquística autosómica dominante.

OBJECTIVE: To determine clinical and laboratorial factors related to progression to chronic kidney disease in patients with autosomal dominant polycystic kidney disease (ADPKD). MATERIAL AND METHODS: Retrolective cohort. We reviewed the files of patients with diagnosis of ADPKD between 1980 and 2008. We collected demographic, clinical and laboratory data. The primary endpoint was the development of advanced kidney disease (GFR estimated < 15 mL/min with MDRD, renal replacement therapy or kidney transplantation). The Cox proportional hazards model was used to investigate the effect of clinical and laboratorial covariates on the progression to advanced kidney disease. RESULTS: Advanced chronic kidney disease developed in 37.4% (n = 34) of the patients with median survival renal of 57 years (IC95% 50.3-63.8). Variables associated with progression to advanced chronic kidney disease in the multivariate analysis were the levels of serum creatinine (HR = 1.59 IC95% 0.99-2.55 p = 0.05) and dyslipidemia (HR = 3.40; IC95% 1.23-9.39; p = 0.01). CONCLUSIONS: Progression to advanced chronic renal failure was common in our population and the predicting factors for progression were the levels of serum creatinine and dyslipidemia.