Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.
The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation. (+info)
Obtaining explicit consent for the use of archival tissue samples: practical issues.
BACKGROUND: Over the past few years, research ethics committees have increasingly demanded explicit consent before archival tissue samples can be used in research projects. Current UK guidance in this area requires an assessment of whether it is "practical" to obtain explicit consent. Ethics committees have little experience or evidence to help them to judge what is "practical" in this context. METHODS: We attempted to obtain general consent for research use of surplus tissue from renal transplant biopsies from the entire patient population of the renal transplant unit in Leicester. The nature of this patient population would be expected to facilitate this task. RESULTS: A total of 495 letters were sent. Attempts were made to contact non-responders when they attended the outpatient clinic. One year after the initiation of the project, the opinions of 26% of the patients had still not been ascertained. CONCLUSIONS: The results confirm that the vast majority of patients are happy for "surplus" biopsy material to be used for research; the situation does not parallel the use of autopsy tissue. A requirement to obtain explicit consent for the study of archival tissue is likely, however, to block or at least seriously delay research, which is contrary to the public interest and specifically may harm the interests of the patients concerned. In the UK, the problem of tissue being used against the wishes of the donor has now been largely replaced by the problem of prohibition of tissue use against the wishes of the donor. (+info)
Musculoskeletal tissue banking in Singapore: 15 years of experience (1988-2003).
PURPOSE: To report 15 years' experience of musculoskeletal tissue banking by the National University Hospital Tissue Bank. METHODS: This study describes the development of Singapore's national bone bank since its establishment in 1988. The bone bank's protocol follows guidelines recommended by the American Association of Tissue Banks and the European Association of Tissue Banks using strict donor selection criteria. Informed consent is obtained from all potential donors for tissue procurement and laboratory tests. Detailed medical history, thorough clinical examination, and chart review is performed for consenting donors. Suitable donors are subjected to tests for hepatitis B, hepatitis C, syphilis, and culture/sensitivity test of tissue for aerobic and anaerobic organisms. For living donors, repeat testing for AIDS and hepatitis C is performed at least 180 days after procurement. Tissue procurement is performed under sterile conditions. Small tissues are procured using the 'sterile double jar technique' and long bones using the 'sterile triple wrap technique', both developed by the author. Deep-frozen bones are gamma irradiated at 25 kilograys. Morsellised bones are lyophilised and gamma irradiated. Meticulous preparation for grafts is performed during transplantation. Antibiotic prophylaxis is used for 2 weeks. RESULTS: The bank maintains a good quality control. In January 2003, it was accredited ISO 9001 status. Up to June 2003, it has procured 440 bones from 440 living donors and 1055 allografts from 63 deceased donors. 854 musculoskeletal transplantations have been performed using tissues processed by the bank. Complication rate encountered was only 2.2%. CONCLUSION: The tissue bank provides high-quality allografts for safe tissue transplantations. (+info)
A non-frozen living tissue bank for allotransplantation using green tea polyphenols.
Generally, mammalian cells and living tissues can be cryopreserved in a frozen state at very low temperatures over a long storage term. The survival rate of cell suspensions is often acceptable however, living tissues suffer a variety of injuries. In this paper, it was demonstrated that the addition of polyphenols extracted from green tea to conventional cell culture medium and tissue compatible liquid, can control cell proliferation and also preserve tissues for several months at ordinary room temperature, including such tissues as blood vessels, cartilage, islet cells and corneas. This protocol allows a non-frozen living tissue bank to be established using the preservation fluid described. (+info)
Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases.
Few detailed clinico-pathological correlations of Parkinson's disease have been published. The pathological findings in 100 patients diagnosed prospectively by a group of consultant neurologists as having idiopathic Parkinson's disease are reported. Seventy six had nigral Lewy bodies, and in all of these Lewy bodies were also found in the cerebral cortex. In 24 cases without Lewy bodies, diagnoses included progressive supranuclear palsy, multiple system atrophy, Alzheimer's disease, Alzheimer-type pathology, and basal ganglia vascular disease. The retrospective application of recommended diagnostic criteria improved the diagnostic accuracy to 82%. These observations call into question current concepts of Parkinson's disease as a single distinct morbid entity. (+info)
Cryopreservation of a whole ovary as a strategy for restoring ovarian function.
PURPOSE: To evaluate whether a total ovary can successfully be cryopreserved and thawed under maintenance of high proportions of structurally normal primordial follicles. METHODS: Porcine ovaries were explanted immediately after slaughtery. Ten ovaries were cooled to -196 degrees C using cryoprotective solution and a computer-controlled freezing technique. Five contralateral ovaries were fixed with formalin for histological examination, the five remaining ovaries were directly plunged in liquid nitrogen. After three weeks of storage, frozen ovaries were thawed and examined by light and electron microscopy. Viability was assessed by evaluation of intact primordial follicles with respect to cellular and intracellular structures. RESULTS: Histological viability of primordial follicles in computer-frozen ovaries was 84.4% (76.1-90.6%), as compared to non-frozen control samples (92-100%; mean 97.6%) and to ovaries plunged in liquid nitrogen without cryoprotection 21.1% (4.5-35.0%). CONCLUSIONS: Cryopreservation of whole ovaries may present a feasible way to maintain high numbers of viable primordial follicles in ovarian tissue retransplantation. (+info)
Assessment of the integrity of human oocytes retrieved from cryopreserved ovarian tissue after xenotransplantation.
BACKGROUND: Previous studies showed that immature oocytes stored in ovarian tissue could develop to the mature stage after transplantation. However, the quality and competency of the oocytes developed in xenografted ovarian tissue have never been investigated. As a pilot study to investigate this uncharted issue, we evaluated microtubule organization and chromatin configuration of human oocytes harvested from xenografted frozen-thawed ovarian tissue. METHODS: Frozen-thawed human ovarian tissue was transplanted into severe combined immunodeficient mice. All animals were stimulated with gonadotrophin from 20 weeks after transplantation. Grafts were recovered 36 h after hCG administration. The oocytes were retrieved from the antral follicles (>2 mm diameter), cultured in vitro, stained for microtubule and chromatin localization. RESULTS: Five oocytes from 21 female mice and seven oocytes from nine male mice were retrieved. Immunocytochemical examinations of these oocytes after in vitro maturation revealed only two developed to the metaphase II stage. Most oocytes were between prophase and metaphase with abnormal microtubule organization and chromatin configuration. CONCLUSIONS: Immature oocytes in stored human ovarian tissue can grow to maturity in host animals after xenotransplantation. Retrieval of oocytes from the xenograft can be carried out and is reproducible. However, many oocytes, grown in host animals and further matured in vitro, showed aberrant microtubule organization and chromatin patterns. (+info)
The derivation of two additional human embryonic stem cell lines from day 3 embryos with low morphological scores.
BACKGROUND: Immune rejection can lead to the failure of human embryonic stem cell (hES cell) transplantation. One approach to address the problem is to establish hES cell line banks. Due to the limited source of human embryos and to ethical reasons, the hES cell lines are not readily available. This study was undertaken to determine whether discarded day 3 embryos with low morphological scores could develop into blastocysts and produce hES cell lines. METHODS: A total of 130 day 3 embryos with low morphological scores were cultured to blastocyst stage, and inner cell masses (ICM) were isolated by immunosurgery. Colonies derived from the ICM were passaged every 4-7 days and evaluated for cell surface markers, differentiation potentials and karyotypes. RESULTS: A total of 19 blastocysts were obtained from 130 embryos (quality score <16), which resulted in the formation of 10 ICM, and two cell lines. Both cell lines satisfied the criteria that characterize pluripotent hES cells. CONCLUSION: Our results suggest that a subset with poor quality day 3 embryos judged on the basis of morphological assessment can form blastocysts and give rise to hES cell lines. (+info)