BioNest User Group Forum
Over 90% of neonatal blood units, collected from the umbilical cord of full-term healthy newborns and generously donated to the community for the purpose of hematopoietic transplantation, do not contain a sufficient number of stem cells to perform this type of transplant and are consequently eliminated with hospital waste.
These precious biological materials can be used to produce new blood components, laboratory reagents and biological drugs.
Adult donor platelets can be a useful source of allogeneic platelet gel.
MedItalia developed the BioNest systems for cord blood and adult donor blood to facilitate the production of the above products.
The BioNest User Group Forum provides a platform for peer-to-peer discussion of technical and clinical issues related to the reagents and blood components prepared with the BioNest systems.
Dear Doctor:
In 2017, MEDITALIA started an international program to support the development of new blood components, reagents and drugs from umbilical cord blood units donated to public banks, but not suitable for transplantation due to insufficient cellular content.
The program, currently in an advanced implementation phase, included the following steps:
- acquisition of the exclusive license of patent ‘Platelet fraction deriving from placental blood’ – EP2304023B1 owned by the Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;
- sponsorship and organizational support of the NUPLA project launched in April 2018, open to the banks of the national Italian Cord Blood Network (ITCBN), coordinated by the National Blood Center (Centro Nazionale Sangue – CNS) and aimed at the study of new products obtained from placental blood and the regulatory review on their industrial use;
- collaboration with the Banc de Sang i Teixits (BST) of Barcelona, Spain, on the standardization and clinical use of new products obtained from placental blood (platelet gel, platelet lysate, ophthalmic eye drops, cell culture additives);
- development, patenting and CE marking of the BioNest systems for placental blood fractionation and for the preparation and therapeutic administration of allogeneic platelet gel from cord blood and adult donor blood;
- set up of a prototype bag specifically designed for the leukoreduction of neonatal red blood cells, suitable for experimental neonatal transfusion protocols.
The collaboration with the CNS, the ITCBN and the BST already allowed to achieve important results:
- validation of a lyophilization procedure of cord platelet lysate;
- preparation of experimental eye drops from cord blood platelet lysate;
- inclusion of cord blood platelets and cord blood plasma in the list of biologicals that can be used for industrial transformation (agreement of the Italian State-Regions Conference of 13 December 2018);
In consideration of the exciting perspectives of these programs, MEDITALIA presents the BioNest UserForum as a platform for peer-to-peer scientific discussion of the above issues and plans to expand the collaboration with Blood Centers and Cord Blood Banks interested in the above developments.
Giovanni Mazzaro
CEO, MEDITALIA SRL
Email: g.mazzaro@meditaliasrl.com
THE NUPLA PROJECT
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