Orthobiologics: Regulation in Different Parts of the World

Grieshober, Jason A.; Fakunle, Eyitayo S.; Gambardella, Ralph A.

doi:10.1007/978-3-662-54181-4_4

Cited by 2 publications

(1 citation statement)

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“…Since the time of the idea generation and proposal preparation, clinical relevance with defined indications and efficacy measures are needed to create a roadmap for on the envisioned solution. Besides, regulatory requirements (Grieshober et al 2017;Lysaght et al 2017) should be known by the research team members from the beginning. For Europe, the Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products (ATMPs), which is an optional classification procedure, and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 is available on http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=-CELEX:32007R1394&from=EN.…”

Section: Facing the Current Challengesmentioning

confidence: 99%

Orthopaedic regenerative tissue engineering en route to the holy grail: disequilibrium between the demand and the supply in the operating room

et al. 2018

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Orthopaedic disorders are very frequent, globally found and often partially unresolved despite the substantial advances in science and medicine. Their surgical intervention is multifarious and the most favourable treatment is chosen by the orthopaedic surgeon on a case-by-case basis depending on a number of factors related with the patient and the lesion. Numerous regenerative tissue engineering strategies have been developed and studied extensively in laboratory through in vitro experiments and preclinical in vivo trials with various established animal models, while a small proportion of them reached the operating room. However, based on the available literature, the current strategies have not yet achieved to fully solve the clinical problems. Thus, the gold standards, if existing, remain unchanged in the clinics, notwithstanding the known limitations and drawbacks. Herein, the involvement of regenerative tissue engineering in the clinical orthopaedics is reviewed. The current challenges are indicated and discussed in order to describe the current disequilibrium between the needs and solutions made available in the operating room. Regenerative tissue engineering is a very dynamic field that has a high growth rate and a great openness and ability to incorporate new technologies with passion to edge towards the Holy Grail that is functional tissue regeneration. Thus, the future of clinical solutions making use of regenerative tissue engineering principles for the management of orthopaedic disorders is firmly supported by the clinical need.

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Section: Facing the Current Challengesmentioning

confidence: 99%