Abstract:
:In order to guarantee the required level of quality for our Bone &Tissue Banking, we evaluated a new CE marked container (CELLFLEX MacoPharma), for packing, transport, processing and storage of bones for therapeutic use. The use of CE marked containers is mandatory for organ and tissue containers (Medical Device Directive 93/42). We carried out a three-phase study: (1)Evaluation, (2) Implementation, (3)Audit The product was evaluated for the following criteria:Dash mechanical resistance, Dash air tightness, Dash fragility, Dash capacity. No damage was observed after the storage period, even after immersion in liquid nitrogen. No breakages were observed after provoked impact tests (pots dropped onto the floor). The pot capacity evaluation showed that the inner pot volume (approximately 500 ml) permits adequate storage of tendons and the majority of bone allografts. In conclusion, this evaluation has shown that the CELLFLEX kit is suitable for long duration preservation of bone allografts even at very low temperature conditions (vapour phase nitrogen). Its format and structure permit preservation of most bone allografts.
journal_name
Cell Tissue Bankjournal_title
Cell and tissue bankingauthors
Villalba R,Fornés G,Dueñas R,García A,Ariza A,Gómez-Villagrán JLdoi
10.1007/s10561-004-1090-3keywords:
subject
Has Abstractpub_date
2004-01-01 00:00:00pages
267-9issue
4eissn
1389-9333issn
1573-6814pii
DO00001090journal_volume
5pub_type
杂志文章abstract::Living tissue engineering for regenerative therapy cannot withstand the usual pharmacopoeia methods of purification and terminal sterilization. Consequently, these products must be manufactured under aseptic conditions at microbiologically controlled environment facilities. This study was proposed to validate BacT/ALE...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9281-1
更新日期:2012-08-01 00:00:00
abstract::Blood samples collected from deceased tissue donors for mandatory transfusion microbiology testing may be taken either at the time of tissue donation, or residual samples may be retrieved from hospital laboratories where they were originally used for ante-mortem tests. In the latter case, sample labelling may not conf...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-008-9071-6
更新日期:2008-12-01 00:00:00
abstract::During August and September of 2013, temperature data loggers were shipped to and from an AATB accredited and FDA registered allograft tissue processing facility in Belgrade, MT (Bacterin International, Inc.) to five warm climate cities (Dallas, TX, El Paso, TX, New Orleans, LA, Phoenix, AZ, and Tampa, FL). Shipping d...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-016-9578-1
更新日期:2016-12-01 00:00:00
abstract::This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21-24 March 2002. There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Ind...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1022811232250
更新日期:2002-01-01 00:00:00
abstract::Although allografts for anterior cruciate ligament (ACL) replacement have shown advantages compared to autografts, their use is limited due to the risk of disease transmission and the limitations of available sterilization methods. Gamma sterilization has shown detrimental effects on graft properties at the high doses...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9289-6
更新日期:2012-08-01 00:00:00
abstract::The goal of periodontal therapy is to prevent periodontal disease progression and to regenerate lost periodontal tissues. Various bone grafts are used alone or in combination with other treatment modalities for periodontal therapy. In literature no reports are presented with block allografts in the treatment of intrab...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-018-09744-5
更新日期:2019-02-11 00:00:00
abstract::The aim of this study is to evaluate the beneficial effect of Myoinositol (MYO) supplement in freezing media on the post thaw sperm quality. Semen samples from 40 normozoospermic men were divided into two aliquots and frozen with simple or 2 mg/mL MYO supplemented freezing medium. Post thaw process including, computer...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-018-9731-0
更新日期:2019-03-01 00:00:00
abstract::It has been predicted that one of the greatest increase in prevalence of diabetes will happen in the Middle East bear in the next decades. The aim of standard therapeutic strategies for diabetes is better control of complications. In contrast, some new strategies like cell and gene therapy have aimed to cure the disea...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9273-1
更新日期:2012-12-01 00:00:00
abstract::Homograft or allograft tissue has been available for use as replacement for diseased valves or reconstruction of major vessels for decades. However, with respect to replacement of diseased valvular tissue the search for the ideal valve still continues. In this review we will discuss the clinical indications, surgical ...
journal_title:Cell and tissue banking
pub_type: 杂志文章,评审
doi:10.1007/s10561-006-9009-9
更新日期:2006-01-01 00:00:00
abstract::Terminal sterilization of musculoskeletal allografts by gamma radiation minimizes the risk of disease transmission but impairs allograft mechanical properties. Commonly employed crosslinking agents can sterilize tissues without affecting mechanical properties adversely; however, these agents are toxic. Genipin is repo...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9335-z
更新日期:2013-09-01 00:00:00
abstract::Recent studies have reported that stem cells can be isolated from a wide range of tissues including bone marrow, fatty tissue, adipose tissue and placenta. Moreover, several studies also suggest that skin dermis could serve as a source of stem cells, but are of unclear phenotype. Therefore, we isolated and investigate...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9471-8
更新日期:2015-06-01 00:00:00
abstract::Human amniotic membrane (HAM) is used as an allograft in regenerative medicine or as a source of pluripotent cells for stem cell research. Various decontamination protocols and solutions are used to sterilize HAM before its application, but little is known about the toxicity of disinfectants on HAM cells. In this stud...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-017-9636-3
更新日期:2017-09-01 00:00:00
abstract::Outcomes for patients with metastatic and recurrent osteosarcoma remain poor and a better understanding of the biology of this malignancy is critical to the development of prognostic biomarkers and novel therapies. The purpose of this study was to establish a biobank of osteosarcoma which has the potential of monitori...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-020-09831-6
更新日期:2020-09-01 00:00:00
abstract::Allogeneic mandibular bone processed by the deep frozen method was used as a biologic crib for mandibular reconstruction. The allogeneic mandible is biocompatible, bioresorbable, of low antigenicity and provides the morphology for symphysis contour, angle of mandible and dental arch form. The particulate cancellous bo...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1023602717328
更新日期:2002-01-01 00:00:00
abstract::Insight into the pathogenesis of neurodegenerative disorders requires accurately categorized postmortem human brain tissue. This article introduces electronic tissue tracking and management as implemented at New York Brain Bank (NYBB) through processing of the brain at fresh state and storing standardized frozen sampl...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-008-9078-z
更新日期:2008-09-01 00:00:00
abstract::To vitrify human amniotic membrane specimens so that the maximum of epithelial cells survives in order to develop a procedure for the eventual vitrification of posterior corneal lamellae without using cryoprotective agents. To assess different methods of tissue sample preparation preceding vitrification. In group 1, t...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-013-9388-7
更新日期:2014-03-01 00:00:00
abstract::Delivering the promise of personalised medicine is the challenge that the current generation of scientists face. The variations in human physiology and disease are considerable, and designing appropriate strategies to deliver what has been promised will require access to tissue from a large number of volunteers. The N...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-010-9212-6
更新日期:2011-02-01 00:00:00
abstract::The use of glycosaminoglycans (GAGs) as the second macromolecular component with collagen for the membrane preparation is based on the idea to create a biodegradable scaffold for new tissue. A hybrid collagen/hyaluronan membrane with specific bubble macrostructure was designed to serve as a synthetic dermal substitute...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/a:1010181925236
更新日期:2000-01-01 00:00:00
abstract::Human amniotic membrane (hAM) represents a tissue that is well established as biomaterial in the clinics with potential for new applications in regenerative medicine. For tissue engineering (TE) strategies, cells are usually combined with inductive factors and a carrier substrate. We have previously recognized that hA...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9454-9
更新日期:2014-06-01 00:00:00
abstract::The regulatory framework of tissue banking introduces a number of requirements for monitoring cleanrooms for processing tissue or cell grafts. Although a number of requirements were clearly defined, some requirements are open for interpretation. This study aims to contribute to the interpretation of GMP or GTP guideli...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9355-8
更新日期:2013-12-01 00:00:00
abstract::A limited number of grafts produced in one batch is the main constrain to validate radiation sterilization dose of amnion and bone grafts according to ISO standard. The validation experiments done were according to ISO 13409 with a slight modification in sampling method. The experiments were carried out three times by...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1010129720363
更新日期:2000-01-01 00:00:00
abstract::On March 19 World Health Organization declare the pandemic situation by outbreak coronavirus disease 2019 in the world. The pressure on the health care system has been very high in several countries. Spanish National Transplant Organization (ONT) have made many efforts in maintaining transplantation activity. Although...
journal_title:Cell and tissue banking
pub_type: 杂志文章,多中心研究
doi:10.1007/s10561-020-09853-0
更新日期:2020-12-01 00:00:00
abstract::Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greate...
journal_title:Cell and tissue banking
pub_type: 杂志文章,评审
doi:10.1007/s10561-011-9276-y
更新日期:2012-12-01 00:00:00
abstract::Repair of damaged cartilage usually requires replacement tissue or substitute material. Tissue engineering is a promising means to produce replacement cartilage from autologous or allogeneic cell sources. Scaffolds provide a three-dimensional (3D) structure that is essential for chondrocyte function and synthesis of c...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-005-5810-0
更新日期:2005-01-01 00:00:00
abstract::In order to solve some of the problems that are affecting tissue banking activities in the world, a new program/project proposal could be prepared by the IAEA and interested Member States in order to implement it in 2009. The main objective of the new program/project proposal could be the following: To consolidate tis...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-008-9092-1
更新日期:2009-05-01 00:00:00
abstract::The amniotic membranes were collected from the placentae of selected and screened donors. Processing was done by washing the fresh amniotic membrane successively in sterile saline, 0.05% sodium hypochlorite solution and sterile distilled water until it was completely cleared of blood particles. The membranes were ster...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/B:CATB.0000034077.05000.29
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:Despite improved surgical techniques and the use of new medication, healing of corneal and conjunctival defects cannot always be achieved. In this connection the clinical use of human amnion, produced by different techniques, has represented a successful alternative for the past ten years. The purpose of the...
journal_title:Cell and tissue banking
pub_type: 临床试验,杂志文章
doi:10.1023/b:catb.0000022222.41304.de
更新日期:2004-01-01 00:00:00
abstract::We describe a rapid and easy technique for the preparation of pre-stripped Descemet membrane (DM) endothelial keratoplasty (DMEK) tissue in the eye bank, without the use of dye or trephining by the eye bank technician. After drawing 2 radial marks 90° apart on the scleral rim of the cornea, a circumferential incision ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-019-09771-w
更新日期:2019-06-01 00:00:00
abstract::In breast cancer, various clinical parameters are assessed to define clinical stage and thus obtain a more accurate prognosis. However, banks of tumor tissues are an important source of material for studies of risk of recurrence and of features governing clinical outcome in breast cancer. Although the heterogeneous ch...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-009-9124-5
更新日期:2009-11-01 00:00:00
abstract::Quality control and standardized preservation methods are essential in the field of transplantation. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade and communications standards that are applicable worldwide and that provide the basis of a quality plan for ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1011576332362
更新日期:2001-01-01 00:00:00