ARDAT Biobank 2024, Version 1.0
Research type
Research Tissue Bank
IRAS ID
328611
Contact name
Janine Kirby
Contact email
Research summary
ARDAT Biobank (Accelerating Research and Development for Advanced Therapies Research Tissue Bank)
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0219
Date of REC Opinion
20 Nov 2024
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The ARDAT (Accelerating Research and Development for Advanced Therapies) Biobank is part of the international ARDAT consortium comprised of scientists and clinicians from academic institutions and pharmaceutical companies in the United Kingdom and overseas. Samples are collected by ARDAT partners from patients with rare genetic diseases receiving cell or gene therapies (Advanced Therapy Medicinal Products (ATMP)) as part of clinical trials or being treated with approved gene or cell therapies. Samples are also collected from untreated patients or healthy donors. Once potential donors are identified, staffs liaise with them, provide a Participant Information Sheet, and ensure they understand what taking part will involve. The Biobank might accept samples from institutions external to the ARDAT consortium under strict conditions.
The Biobank stores samples from existing collections or future studies that include blood (including for DNA analysis), serum, plasma, Peripheral Blood Mononuclear Cells, cerebrospinal fluid and saliva. Samples are frozen and kept in a secure storage facility. Data will be obtained from the patients’ medical record and will be pseudonymised prior to their transfer to the Biobank. The Biobank stores data including sex, date of birth and clinical information (i.e. medical condition, treatment administered, immunosuppressive treatment) in a dedicated secure database.Research programme
The principal research area the ARDAT Biobank focuses on is the better understanding of the immunological and non-immunological responses to Advanced Therapy Medicinal Products (ATMP), specifically gene and cell therapies, that affects their safety, efficacy and persistence as a therapeutic tool to treat patients affected by rare genetic diseases. The Biobank will provide samples and data to researchers from the ARDAT consortium working on patients’ pre-existing immunity to some of these advanced therapies and on the immunological and metabolic responses that evolve after treatment with ATMPs. Scientists conducting these research programmes will mostly be from Universities and other academic institutions but will also include commercial partners. The research programmes supported by the ARDAT Biobank will improve the tolerability and accessibility of advanced therapies for patients with genetic diseases, contributing to the improvement of ATMPs and the development of next generation therapies for future patients.
Storage license
12182
RTBTitle
ARDAT Biobank (Accelerating Research and Development for Advanced Therapies Research Tissue Bank)
Establishment organisation
The University of Sheffield
Establishment organisation address
The Sheffield Biorepository, School of Medicine and Population Health
The Medical School
Beech Hill Road, Sheffield
S10 2RX