A recent report demonstrated that a laboratory-grown neobladder tissue could be successfully used for cystoplasty in young patients with myelomeningocele who were otherwise healthy. This remarkable achievement portends well for the application of tissue engineering/regenerative medicine technologies to the treatment of end-organ failure due to a variety of causes (ie, congenital, acquired, age or disease related). Nonetheless, the broader clinical use of these groundbreaking technologies awaits improved understanding of endogenous regenerative mechanisms, more detailed knowledge of the boundary conditions that define the current limits for tissue repair and replacement in vivo, and the parallel development of critical enabling technologies (ie, improved cell source, biomaterials, bioreactors). This brief report will review a number of the most salient features and recent developments in this rapidly advancing area of medical research and detail some of our own experience with bladder and skeletal muscle regeneration and replacement as examples that highlight both the promise and challenges facing regenerative medicine/tissue engineering.
"The multidisciplinary approach of RM argues the need for strategic alliances and collaboration to further advance scientific research, increase access to funds and improve translation capabilities and production know-how (Corona et al. 2010; Pangarkar et al. 2010). There has been limited research into the application of OI within the RM industry (Fetterhoff and Voelkel 2006; Chiaroni, Chiesa, and Frattini 2009, Rasmussen 2010; Bianchi et al. 2011), and as far as we are aware, no such research in CTs has been undertaken. "
[Show abstract][Hide abstract] ABSTRACT: Regenerative medicine therapies are showing great clinical promise in providing cures to life-threatening diseases such as cancer and diabetes. However, little emphasis has been placed on the industrialisation of these therapies for commercial purposes. The inability to scale production up and out to meet pending demand is of increasing concern to both regulators and funding agencies. Using an open innovation theoretic lens, this paper explores the importance of involving commercial partners within the lengthy research and development phases. We adopt a case study method to show that laboratory processes that incorporate innovative manufacturing techniques produce significant reduction in cost of quality (errors) and improved scalability, while satisfying regulatory requirements. We demonstrate that this approach enables faster industrialisation, and improves the funding efficiency of clinical trial outcomes in terms of quality, cost and commercial success of therapies.
International Journal of Production Research 11/2014; 52(21). DOI:10.1080/00207543.2014.962115 · 1.48 Impact Factor
"New options, like injection of micro-RNAs  or predifferentiation of larger constructs in a bioreactor [42–44] need to be considered as additional possibilities to achieve a more constant differentiation for in vivo applications. "
[Show abstract][Hide abstract] ABSTRACT: Generation of axially vascularized muscle tissue constitutes a promising new approach to restoration of damaged muscle tissue. Mesenchymal stemcells (MSC), with their ability to be expanded to large cell numbers without losing their differentiation capacity into the myogenic lineage, could offer a promising cell source to generate neomuscle tissue. In vitro experiments showed that cocultures of primary myoblasts and MSC undergo myogenic differentiation by stimulation with bFGF and dexamethasone. A newly developed AV-Loop model with neurotization was established in this study. It encompasses axial vascularization and the additional implantation of a motor nerve serving as myogenic stimulator. Myoblasts and MSCs were coimplantated in a prevascularized isolation chamber. Cells were differentiated by addition of bFGF and dexamethasone plus implantation of a motor nerve. After 8 weeks, we could observe areas of myogenic differentiation with α -sarcomeric actin and MHC expression in the constructs. Quantitative PCR analysis showed an expression of myogenic markers in all specimens. Thus, neurotization and addition of bFGF and dexamethasone allow myogenic differentiation of MSC in an axially vascularized in vivo model for the first time. These findings are a new step towards clinical applicability of skeletal muscle tissue engineering and display its potential for regenerative medicine.
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