(1) Bioresource Overview
York Tissue Bank (YTB) is hosted within the Centre for Immunology and Infection in the Department of Biology and Hull York Medical School of the University of York and is approved by the Health Research Authority (National Research Ethics Service) Leeds East Research Ethics Committee (ref: 15/YH/0016); our license number granted by the Human Tissue Authority under section 16 (2) (e) (ii) of the Human Tissue act 2004 is 12604. The tissue bank is funded by the University of York with a cost-recovery model implemented for applicants to the biobank.
UK National Research Ethics Service (NRES 11/YH/0321) and Research & Development at York Teaching Hospital NHS foundation Trust (YORA01992) ethically approved a study entitled ‘ex vivo cervical implant systems for the analysis of viral infections and transmission blockade’ with the University of York as sponsor. Tissue was initially collected to meet the requirements of this study but latterly, following amendment (substantial amendment 2 – 17/9/15) to the ethically approved protocol and re-consent of patients, where possible, specifically for the tissue bank and henceforth available for suitable tissue bank applicants to access.
Description: samples were collected at York Teaching Hospital NHS Foundation Trust, The York Hospital, Wigginton Road York, UK, YO31 8HE.
Collection period was between 23rd March 2012 and 19th June 2014.
Temporal coverage for accessibility
No end date is applicable.
Written informed consent using York Tissue Bank patient information sheets and consent forms was obtained from women willing to donate uterine cervical tissue who had normal cervical smears and were undergoing a planned hysterectomy for their own health. After hysterectomy the uterus was transported to the York Teaching Hospital NHS Foundation Trust histopathology department and reviewed macroscopically by the consultant histopathologist. Approximately 90% of normal, healthy, cervix was released and transported to the university for codification, processing and storage .
Released cervical tissue was transferred into leakproof sterile sample pots containing a transportation medium (Leibovitz’s L-15 medium containing heat-inactivated single-batch 10% foetal bovine serum (FBS), 100 U/ml penicillin, 100 μg/ml streptomycin, and 2.5 μg/ml amphotericin B [all from Invitrogen, Paisley, UK]) and cooled to 4°C for transportation to the University of York. All samples subsequently underwent processing within four hours of surgery. Endo- and ecto-cervix were separated visually and tissue was cut into approximately 1 cm3 cervical explant samples containing mucosal and submucosal tissue to maintain tissue architecture .
Type of long-term preservation
Cervical explant samples (∼1 cm3) were placed individually into 2 ml cryovials on ice containing 1 ml of a pre-cooled (4°C) freezing medium (90% FBS with 10% dimethyl sulfoxide) sufficient to ensure cryoprotectant reached all the tissue. Cryovials were then transferred immediately to a control rate freezer pre-cooled to 4°C (Planer KRYO560-16, Planer PLC, Sunbury-on-Thames, UK) and explants were cooled from 4°C to –50°C at 1°C/min and then from –50°C to –120°C at 10°C/min before transfer to liquid nitrogen for tissue banking .
Liquid nitrogen: –196°C.
Shipping temperature from patient/source to preservation or research use
0–4°C (on ice).
Shipping temperature from storage to research use
–78°C (on dry ice).
Quality assurance measures
- Cervical tissue was recovered and processed within four hours of surgery.
- Reagents used in the transport and freezing were prepared freshly and were within their expiration date.
- Freezer chamber temperature data was recorded as evidence of successful cycle completion; samples were transferred to liquid nitrogen immediately after controlled freezing.
- Liquid nitrogen levels are monitored and refilled by centre staff; spare liquid nitrogen is always available at the university.
- Access to liquid nitrogen tanks is restricted to centre staff/students working on clinical research projects.
- Liquid nitrogen tanks are stored in a purpose-built environmentally regulated room with oxygen level detectors and a constant supply of electricity with a backup generator in case of power outage.
- Liquid nitrogen tank temperatures are constantly monitored and logged; tanks are connected to an alarm system (mains operated and with a battery backup) that notifies centre staff if logged temperatures reach >–160°C or <–200°C for 30 minutes. Centre staff respond to call-outs within 30 minutes to investigate cause of alarm.
- YTB has an internal standard operating procedure in place for quality management of samples and storage in addition to regular internal audits.
Source of associated data
The tissue was designated to be normal on histological examination; donor date of birth is available.
UK National Research Ethics Service (NRES 11/YH/0321) and Research & Development at York Teaching Hospital NHS foundation Trust (YORA01992) ethically approved the original study entitled ‘ex vivo cervical implant systems for the analysis of viral infections and transmission blockade’, with University of York acting as the study sponsor. An amendment was latterly submitted to the Health Research authority ethics committee who approved the collection of cervical tissue for storage for future use under the universities HTA license within the York Tissue Bank; some patient samples collected prior to the amendment were re-consented, where possible. Written informed consent was obtained from women with normal cervical smears who needed to undergo a planned hysterectomy for their own health and who were willing to donate cervical tissue.
(3) Bioresource description
Cervical tissue explant.
York Tissue Bank.
York Tissue Bank, Centre for Immunology and Infection, Department of Biology and Hull York Medical School, Wentworth Way, University of York, York, YO10 5DD, UK.
+44 (0)1904 32 8867
Cell and tissue biobank.
Type of sampling
Disease status of patients/source
Clinical characteristics of patients/source
Healthy women undergoing planned hysterectomy.
Size of the bioresource
The bioresource contains cervical tissue from 16 women: ectocervix is available from every donor with a total of 195 samples available; endocervix is additionally available from two of 16 donors with four tissue samples available from each donor.
|Donor number||Number of ectocervix samples||Number of endocervix samples|
Vital state of patients/source
Clinical diagnosis of patients/source
Healthy women undergoing planned hysterectomy.
Cervical tissue: approximately 1 cm3 tissue samples.
Size of the bioresource
The bioresource described includes cervical tissue from 16 women.
Application process is by request form completion accessible from the York Tissue Bank webpage with submission to the tissue bank manager who will pre-screen the application form for appropriate justification of use prior to review by the York tissue bank management group (YTBMG). Our SOP060, available from the tissue bank manager, details the process and paperwork required. All human sample transfers out of the university are under the auspices of a Material Transfer Agreement and only to a recipient that has appropriate ethical approval from a recognised research ethics committee or they are operating under a valid and appropriate HTA license, as evidenced by submission of a copy of their approvals/licenses or approval from the designated individual at the recipient institute. We require completion of a risk assessment for the handling and transportation of the sample(s) to the recipient. 16 donor samples are available, consisting of 203 1 cm3 cervical explant samples. Costs are required to cover expenses associated with shipment to the applicant. Access is restricted to research applications from qualified professionals that have been ethically approved by the applicants’ local research ethics committee. Applicants must guarantee to acknowledge the York Tissue Bank in any scientific publication. Research at the University of York and its collaborative partners is governed by the universities research policies and codes of practice https://www.york.ac.uk/staff/research/governance/research-policies/.
(4) Reuse potential
The cervical tissue could be used in any research project requiring normal primary human uterine cervical tissue; samples were originally obtained to establish an ex vivo organo-typical model to conduct viral infection studies of sexually transmitted diseases, as has previously been described for HIV infection studies . Cryopreserved cervical tissue has been demonstrated to remain viable with preserved tissue architecture after thawing [2, 4, 5] and retain the ability to be infected . The 1 cm3 cervical explant samples available can be further processed (dissected into smaller pieces, section etc.) into viable appropriate sized pieces for the respective applicant so each cervical explant sample has the potential for multiple experiments or replicates.