Abstract:
:Although therapeutics derived from biological sources have been subjected to regulatory oversight for some time, the products used in transplantation procedures have historically been exempt from this oversight. These products have been viewed as being part of medical practice rather than as the result of mainstream pharmaceutical manufacture. Furthermore, their unique source makes them difficult to assess in traditional regulatory systems based on the tenets of pharmaceutical quality control. With the increasing use of transplantation therapies to both replace dysfunctional organs and to influence genetic and metabolic processes, public health concerns on these therapies have increased. In addition, it is recognized that therapeutic claims for some of these interventions need to be properly assessed. These considerations have led the established regulatory agencies of the developed world to develop new regulatory paradigms for the products of transplantation practice. While a number of concerns have driven these developments, the minimization of infectious disease risk remains the paramount driver for introducing these regulatory systems. More than the regulation of medicines and medical devices manufactured in traditional pharmaceutical modes, the regulation of cell and tissue products is intimately linked to areas of public health policy and funding. This places regulators in a challenging position as they attempt to reconcile their roles as independent assessors with the needs of the overall public health framework. This is particularly difficult when considering measures which may affect access to life saving therapies. Regulators have recognized the need to assess these therapies through systems which incorporate consideration of risk-benefit ratios and include mechanisms for transparent and accountable release of products when full compliance to traditional concepts of manufacturing practice is not possible.
journal_name
Cell Tissue Bankjournal_title
Cell and tissue bankingauthors
Farrugia Adoi
10.1007/s10561-006-9012-1subject
Has Abstractpub_date
2006-01-01 00:00:00pages
325-35issue
4eissn
1389-9333issn
1573-6814journal_volume
7pub_type
杂志文章,评审abstract::Stem cell therapy is in constant need of new cell sources to conceive regenerative medicine approaches for diseases that are still without therapy. Scientists drew the attention toward amniotic membrane and amniotic fluid stem cells, since these sources possess many advantages: first of all as cells can be extracted f...
journal_title:Cell and tissue banking
pub_type: 杂志文章,评审
doi:10.1007/s10561-014-9428-y
更新日期:2014-06-01 00:00:00
abstract::Recently Bulgarian Bone Marrow Donors Registry (BBMDR) has been established and since August 2005 it has been a member of Bone Marrow Donors Worldwide. Currently the number of healthy donors included in the BBMDR is relatively low. All donors included in the BBMDR are typed for HLA-A, -B, -DRB loci. Phylogenetic analy...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-007-9046-z
更新日期:2008-12-01 00:00:00
abstract::Decellularised tissue allografts have been used in reconstructive surgical applications and transplantation for many years. Some of the current methods of sterilisation have a detrimental effect on the tissue graft structure and function. The anti-microbial activity of cupric ions and hydrogen peroxide (H2O2) are well...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-017-9660-3
更新日期:2017-12-01 00:00:00
abstract::Demineralized freeze-dried bone allograft (DFDBA) has been used extensively in periodontal therapy. Questions have been raised however, about the osteogenic potential of the variety of grafts available. In India the cost factor is another important consideration. The aim of this study therefore was to evaluate the cli...
journal_title:Cell and tissue banking
pub_type: 杂志文章,随机对照试验
doi:10.1007/s10561-014-9481-6
更新日期:2015-09-01 00:00:00
abstract::We report two cases of severe endophthalmitis, which were caused by Serratia marcescens, and developed in the immediate postoperative period in two recipients of corneal grafts from the same donor. The cause of the donor's death was massive CVA. He had been on mechanical ventilation for 12 days before he died, and had...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/A:1021839711471
更新日期:2002-01-01 00:00:00
abstract::This study was conducted to evaluate the effect of combined cysteine and glutathione in soy lecithin-based semen extender on post-thawed ram sperm quality. A total of 28 ejaculates were collected twice a week (from four rams) during breeding season. In each replicate, semen samples (n = 4, one ejaculate for each ram) ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9488-z
更新日期:2015-09-01 00:00:00
abstract::Cryopreserved (CryoPA) and Glycerol-preserved (GPA) skin allografts are commonly used in the treatment of severe burn injuries. However, comparable data on their differences in clinical outcome is scarce. This retrospective review aims to study the effect of allograft viability on clinical outcomes. The records of 48 ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9254-4
更新日期:2012-06-01 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::Osteochondral defects can degenerate into osteoarthritis and currently there are no good treatment alternatives available to most Orthopaedic surgeons. Osteochondral allografting can restore damaged joint surfaces but its clinical use is limited by poor access to high quality tissue. Vitrification of osteochondral tis...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-006-9023-y
更新日期:2007-01-01 00:00:00
abstract::The viscoelastic and inertial properties of the arterial wall are responsible for the arterial functional role in the cardiovascular system. Cryopreservation is widely used to preserve blood vessels for vascular reconstruction but it is controversially suspected to affect the dynamic behaviour of these allografts. The...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-005-0655-0
更新日期:2006-01-01 00:00:00
abstract::We evaluated the value of the 'alternative slices mirror image method' used in prostate tissue banking in terms of predicting the sampling of cancerous tissue while preserving the pathological prognostic information. The concordance of diagnosis between banked sections and their mirror image paraffin- sections was stu...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9284-y
更新日期:2012-12-01 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::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 Direc...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-004-1090-3
更新日期:2004-01-01 00:00:00
abstract::Recovered human and animal tissues are used extensively in surgery for wound repair and reconstruction. In preparation for the validation of chemical disinfection and radiation sterilization processes, studies were performed on the development and validation of quantitative bioburden recovery methods for human bone an...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-010-9238-9
更新日期:2012-03-01 00:00:00
abstract::Despite a plethora of studies on overall attitudes related to organ donation in a health care setting, little is known as to whether or not medical students at various levels of undergraduate training have distinctive attitudes towards donation. The purpose of this study was to analyze attitudes of first- and sixth-ye...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9491-4
更新日期:2015-09-01 00:00:00
abstract::Autologous chondrocyte implantation has been shown to be a promising method for treatment of deep articular cartilage defects. The hyaline cartilage formed by implanted autologous chondrocytes has biomechanical properties similar to those of natural articular cartilage. Between June 2006 and September 2008 we performe...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-009-9163-y
更新日期:2010-05-01 00:00:00
abstract::Mesenchymal stem cells (MSCs) have vast potential in cell therapy, and are experimentally used in the clinic. Therefore, it is critical to find a serum- and xeno-free cryopreservation method. The aim of this study was to compare two serum- and xeno-free cryoprotectants for MSCs. Adipose tissue MSCs (Ad-MSCs) and bone ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-014-9463-8
更新日期:2015-06-01 00:00:00
abstract::During bone allograft processing, despite stringent donor screening and use of aseptic techniques, microbial invasion may occur due to the porous nature of the graft and cause potentially fatal infections. The aim of the present study was to prepare bone allograft with and without gentamicin and to compare bioburden a...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-019-09763-w
更新日期:2019-06-01 00:00:00
abstract::The amnionic membrane is a rich source of multipotent mesenchymal stromal cells (hAMSC), which are readily available and show a potential use in regenerative medicine and tissue engineering. Before these cells can be applied clinically, careful characterization is necessary, especially as primary cells are known to ch...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-013-9415-8
更新日期:2014-06-01 00:00:00
abstract::The purpose of the present research was: 1. To investigate the opportunity of application of allogen osteoplastic materials such as Lioplast, received in Samara Tissue Bank of Samara State Medical University. 2. To work out a new technique of producing lyophilized allogen osteoplastic materials, such as Lioplast, with...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-004-7254-3
更新日期:2005-01-01 00:00:00
abstract::The aim of this study is to set up a standardized and reproducible method to determine the potency (= stem cell content) of human conjunctival cell cultures by means of immunofluorescence-based analyses. This will help the development of new Advanced Therapy Medicinal Products (ATMPs) to use in future cell therapy cli...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-020-09874-9
更新日期:2020-10-13 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::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::The study aim was to identify risk factors for morphological rejection of aortic and pulmonary valves for transplantation that could be used to optimize donor selection. The files of all Dutch heart valve donors, donating in a 2.5 years period, whose hearts were processed at Heart Valve Bank Rotterdam, were reviewed f...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-011-9267-z
更新日期:2013-03-01 00:00:00
abstract::To compare the quality of the repair tissue in three-dimensional co-culture of human chondrocytes implanted in an in vivo model. Six cadaveric and five live human donors were included. Osteochondral biopsies from the donor knees were harvested for chondrocyte isolation. Fifty percent of cadaveric chondrocytes were exp...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-017-9635-4
更新日期:2017-09-01 00:00:00
abstract::In India, the procurement of tissues for transplantation is governed by the Transplantation of Human Organs Act, 1994. However, although this law exists, it is primarily applied to organ transplantation and rules and regulations that are specific to tissue banking have yet to be developed.The Tata Memorial Hospital (T...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1023/B:CATB.0000007026.00604.97
更新日期:2003-01-01 00:00:00
abstract::Good manufacturing practices guidelines require safer and standardized cell substrates especially for those cell therapy products to treat ocular diseases where fibroblasts are used as feeder layers. However, if these are unavailable for stem cells culturing, murine fibroblasts are regularly used, raising critical iss...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-012-9325-1
更新日期:2013-06-01 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::Malaria is one of the exclusion criteria used in selecting tissue donors and the absence of this information can lead to rejection of tissues for transplant. The studies on the malaria parasite have been confined to low dose attenuation of parasites in blood for transfusion purposes. There is no published information ...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-018-9683-4
更新日期:2018-06-01 00:00:00
abstract::Appropriate animal models are critical to conduct translational studies of human disorders without variables that can confound clinical studies. Such analytic methods as patch-clamp electrophysiological and voltammetric recordings of neurons in brain slices require living brain tissue. In order to obtain viable tissue...
journal_title:Cell and tissue banking
pub_type: 杂志文章
doi:10.1007/s10561-013-9380-2
更新日期:2014-03-01 00:00:00