Abstract
Bioartificial kidneys (BAKs) combine a conventional hemofilter in series with a bioreactor unit containing renal epithelial cells. The epithelial cells derived from the renal tubule should provide transport, metabolic, endocrinologic and immunomodulatory functions. Currently, primary human renal proximal tubule cells are most relevant for clinical applications. However, the use of human primary cells is associated with many obstacles, and the development of alternatives and an unlimited cell source is one of the most urgent challenges. BAKs have been applied in Phase I/II and Phase II clinical trials for the treatment of critically ill patients with acute renal failure. Significant effects on cytokine concentrations and long-term survival were observed. A subsequent Phase IIb clinical trial was discontinued after an interim analysis, and these results showed that further intense research on BAK-based therapies for acute renal failure was required. Development of BAK-based therapies for the treatment of patients suffering from end-stage renal disease is even more challenging, and related problems and research approaches are discussed herein, along with the development of mobile, portable, wearable and implantable devices.
Highlights
Bioartificial kidneys (BAKs) combine a conventional hemofilter in series with a bioreactor unit containing renal epithelial cells
We found that primary human renal proximal tubule cell (HPTC) would not grow and survive on polysulfone/polyvinylpyrrolidone (PSF/ PVP) membranes, and in this case, cell performance could not be sufficiently improved by a single coating of a suitable extracellular matrix (ECM) consisting of collagen IV
The results showed that differentiated functions such as a-methylglucopyranoside uptake or g-glutamyl transferase (GGT) activity were compromised in comparison to primary HPTCs, and the levels of activity observed in primary cells were not restored after removal of the transgenes
Summary
Given the problem of cell sourcing, the costs associated with in-center BAK treatment and the issues associated with mobile devices, the development of BAK-based therapies for ESRD patients would take many more years of intense research. The most straightforward path ahead may involve the development of immobile devices for the treatment of ARF. It would be critical to design and synthesize novel membrane materials with cytocompatibility, antifouling and anticoagulation properties, as well as other features such as hydrodynamic permeability and selectivity. Progress in this multidisciplinary research area would provide a solid basis for the development of more advanced BAK-based therapies
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