European Quality System for Tissue Banking

Manyalich, M.; Navarro, Aurora; Koller, Ján; Loty, B.; Guerra, Arnaud de; Vabels, G; Fornasari, Pier Maria; Costa, Alessandro Nanni; Siska, Ioana Raluca; Hirn, Martti; Franz, Norbert; Miranda, B.; Kamiński, Adam; Uhrynowska, I; Baare, J. Van; Trias, Esteve; Fernández, Cárdenas; By, T de; Poniatowski, Stefan; Carbonell, Ramón

doi:10.1016/j.transproceed.2009.06.157

Cited by 15 publications

(8 citation statements)

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“…Concerns on the potential infective risks were raised, though since 1989 only 2 documented cases of HIV were reported with a risk rate of 1:1.6 milions [20]. Anyway, current procedure for donor bone procurement and processing are designed to significantly limit the possible transmission of knonw pathogens [21]. …”

Section: Bone Graftsmentioning

confidence: 99%

“…This feature may suggest their safe use as it does not imply any kind of “ex vivo ” osteogenic induction prior to “in vivo ” inoculation. Nonetheless, the production of clinical-grade MSCs, requires dedicated cell factories for their “ex vivo ” large scale culture amplification; these are GMP-proof facilities that need to comply to the same regulations required for the drug manufacturing industries, as culture-amplified cells, according to European tissue banking rules, are considered as medicinal products [21, 188]. …”

Section: Emerging Strategies For Bone Substitutionmentioning

confidence: 99%

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Bone substitutes in orthopaedic surgery: from basic science to clinical practice

Campana

Milano

Pagano

et al. 2014

J Mater Sci: Mater Med

909

799

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Bone substitutes are being increasingly used in surgery as over two millions bone grafting procedures are performed worldwide per year. Autografts still represent the gold standard for bone substitution, though the morbidity and the inherent limited availability are the main limitations. Allografts, i.e. banked bone, are osteoconductive and weakly osteoinductive, though there are still concerns about the residual infective risks, costs and donor availability issues. As an alternative, xenograft substitutes are cheap, but their use provided contrasting results, so far. Ceramic-based synthetic bone substitutes are alternatively based on hydroxyapatite (HA) and tricalcium phosphates, and are widely used in the clinical practice. Indeed, despite being completely resorbable and weaker than cortical bone, they have exhaustively proved to be effective. Biomimetic HAs are the evolution of traditional HA and contains ions (carbonates, Si, Sr, Fl, Mg) that mimic natural HA (biomimetic HA). Injectable cements represent another evolution, enabling mininvasive techniques. Bone morphogenetic proteins (namely BMP2 and 7) are the only bone inducing growth factors approved for human use in spine surgery and for the treatment of tibial nonunion. Demineralized bone matrix and platelet rich plasma did not prove to be effective and their use as bone substitutes remains controversial. Experimental cell-based approaches are considered the best suitable emerging strategies in several regenerative medicine application, including bone regeneration. In some cases, cells have been used as bioactive vehicles delivering osteoinductive genes locally to achieve bone regeneration. In particular, mesenchymal stem cells have been widely exploited for this purpose, being multipotent cells capable of efficient osteogenic potential. Here we intend to review and update the alternative available techniques used for bone fusion, along with some hints on the advancements achieved through the experimental research in this field.

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Section: Bone Graftsmentioning

confidence: 99%

Section: Emerging Strategies For Bone Substitutionmentioning

confidence: 99%

Bone substitutes in orthopaedic surgery: from basic science to clinical practice

Campana

Milano

Pagano

et al. 2014

J Mater Sci: Mater Med

909

799

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“…In concordance with EUTCD, training procedures are performed every year and kept up to date in case of updates [ 70 ]. It must be underscored that additional support on training of tissue establishments personnel was given through EU-funded projects, such as European Quality System for Tissue Banking (EQSTB) [ 71 ] and European Good Tissue Practices (EuroGTPs, ). The good practices on quality management, responsible persons and personnel developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated guide to the quality and safety of tissues and cells.…”

Section: Limits and Risksmentioning

confidence: 99%

From Donor to Patient: Collection, Preparation and Cryopreservation of Fecal Samples for Fecal Microbiota Transplantation

Nicco

Paule²,

Konturek

et al. 2020

Diseases

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Fecal Microbiota Transplantation (FMT) is suggested as an efficacious therapeutic strategy for restoring intestinal microbial balance, and thus for treating disease associated with alteration of gut microbiota. FMT consists of the administration of fresh or frozen fecal microorganisms from a healthy donor into the intestinal tract of diseased patients. At this time, in according to healthcare authorities, FMT is mainly used to treat recurrent Clostridium difficile. Despite the existence of a few existing stool banks worldwide and many studies of the FMT, there is no standard method for producing material for FMT, and there are a multitude of factors that can vary between the institutions. The main constraints for the therapeutic uses of FMT are safety concerns and acceptability. Technical and logistical issues arise when establishing such a non-standardized treatment into clinical practice with safety and proper governance. In this context, our manuscript describes a process of donor safety screening for FMT compiling clinical and biological examinations, questionnaires and interviews of donors. The potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation must be taken urgently into consideration. We discuss a standardized procedure of collection, preparation and cryopreservation of fecal samples through to the administration of material to patients, and explore the risks and limits of this method of FMT. The future success of medicine employing microbiota transplantation will be tightly related to its modulation and manipulation to combat dysbiosis. To achieve this goal, standard and strict methods need to be established before performing any type of FMT.This procedure could be also indicated to treat other diseases associated with alteration of gut microbiota [5].The use of FMT was proposed from the 4th century AD and has been widely studied and documented since 2013, when the U.S. Food and Drug Administration approved FMT for the treatment of recurrent and refractory Clostridium difficile infections. In the 4th century yellow soup, as it was called in China, represented the feces used in patients with severe diarrhea. Accounts of treatment with fresh or fermented fecal suspensions applied in patients with gastrointestinal disorders, including diarrhea, constipation, and abdominal pain were described until the Chinese Ming Dynasty in the 16th century [6,7]. More recently, Eiseman and his colleagues successfully treated patients with FMT for Pseudomembranous colitis, in 1958, the first report in the medical literature [8]. With the increasing numbers of trials and the sharing of results around the world, mixed results have been observed, suggesting that heterogeneity in donor stool may play a role in patient response. Studies hypothesize that the microbiome is associated with a given indication [6][7][8]. Thus, fecal material collections should be informed by the health of the donors but also categorized to associate the donor with a recipient as part of a selection s...

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“…However, they present limited osteoinductive properties and their availability is limited due to the inadequate stock in allograft biobanks caused by a significant cost for the collection and the storage of the tissues . Safety issues of these materials also remain a major concern although screening for diseases or infections have been improved . From a regenerative point of view, allo‐and xenografts have more chances to be rejected than autografts and osseointegration is slower due the treatments employed to avoid immunogenicity and the transmission of deceases/infections .…”

Section: Introductionmentioning

confidence: 99%

Optimized Bioactive Glass: the Quest for the Bony Graft

Granel

Bossard

Nucke

et al. 2019

Adv Healthcare Materials

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Technological advances have provided surgeons with a wide range of biomaterials. Yet improvements are still to be made, especially for large bone defect treatment. Biomaterial scaffolds represent a promising alternative to autologous bone grafts but in spite of the numerous studies carried out on this subject, no biomaterial scaffold is yet completely satisfying. Bioactive glass (BAG) presents many qualifying characteristics but they are brittle and their combination with a plastic polymer appears essential to overcome this drawback. Recent advances have allowed the synthesis of organic–inorganic hybrid scaffolds combining the osteogenic properties of BAG and the plastic characteristics of polymers. Such biomaterials can now be obtained at room temperature allowing organic doping of the glass/polymer network for a homogeneous delivery of the doping agent. Despite these new avenues, further studies are required to highlight the biological properties of these materials and particularly their behavior once implanted in vivo. This review focuses on BAG with a particular interest in their combination with polymers to form organic–inorganic hybrids for the design of innovative graft strategies.

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European Quality System for Tissue Banking

Cited by 15 publications

References 0 publications

Bone substitutes in orthopaedic surgery: from basic science to clinical practice

Bone substitutes in orthopaedic surgery: from basic science to clinical practice

From Donor to Patient: Collection, Preparation and Cryopreservation of Fecal Samples for Fecal Microbiota Transplantation

Optimized Bioactive Glass: the Quest for the Bony Graft

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