Background

Biobanks have recently become an important tool in clinical research. The availability of biological samples collected and stored following strict quality standards is crucial in biomedical and translational research in Multiple Sclerosis (MS), to better understand disease pathogenesis, identify biomarkers of diagnosis, prognosis and treatment response.

The Regional Reference Multiple Sclerosis Center (CRESM) at the S. Luigi Gonzaga Hospital provides comprehensive care for more than 2000 MS patients. It has been operational since 2013 in transforming the reserve of biological samples into a structured biobank.

Objectives

To describe the establishment of a structured MS biobank starting from a collection of biological samples and the process for providing scientists with biological samples and associated data.

Methods

According to guidelines by the “Biobanking and Biomolecular Resources and Research Infrastructure” (BBMRI), the steps for the BB-CRESM establishment were: Institutional commitment; Biobank management and staffing; Development of procedures to address ethical, legal, and social issues, according to the General Data Protection Regulation, in collaboration with a bioethicist.

All technical procedures were included into Standard Operating Procedures manual.

Results

BB-CRESM is a structural part of the Piedmont Regional Health Service. The General Director of San Luigi Hospital approved its Regulation, selected the BB-CRESM director and the members of the Scientific Committee.

BB-CRESM is a non-profit organization supported by the Italian Multiple Sclerosis Foundation.

Specific protocols regulate the timing and modalities of biological sample collection, ensuring privacy of subjects.

A detailed description of the biobank is in-person explained to each patient or healthy subject with the help of a leaflet; following which the informed consent is obtained. The Ethical Committee approved both the leaflet and the informed consent model.

Scientists can apply to the director of BB-CRESM specifying number, types and quantity of required samples and data. The samples can be distributed if a) they are used for a research project approved by an Ethic Committee; b) the research project is approved by the Scientific Committee; c) the scientist signs the Material Transfer Agreement; d) scientist agrees to share crude data with BB-CRESM e) scientist contributes to BB-CRESM collection and shipment expenses.

Since 2013, more than 1000 participants (healthy controls and MS patients) have enrolled in the BB-CRESM; over 20000 tubes of biological material (cerebrospinal fluid, serum, plasma, PBMCs, RNA and DNA) have been collected and stored.

Conclusions

BB-CRESM collects, stores and distributes biological samples along with associated data ensuring quality of collection and bio-banking according to BBMRI.

MS researchers can contact BB-CRESM at biobanca.cresm@sanluigi.piemonte.it.