Closing the European gap towards a large scale ex vivo platelet production built upon a silk-based scaffold bioreactor

Project Information

SilkPlatelet

Grant agreement ID: 101058349

DOI

10.3030/101058349

Project closed

EC signature date 25 July 2022

Start date 1 October 2022

End date 31 December 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 1 798 152,50

EU contribution

€ 1 798 152,50

Coordinated by

UNIVERSITA DEGLI STUDI DI PAVIA
Italy

Periodic Reporting for period 1 - SilkPlatelet (Closing the European gap towards a large scale ex vivo platelet production built upon a silk-based scaffold bioreactor)

Reporting period: 2022-10-01 to 2023-09-30

Summary of the context and overall objectives of the project

Platelets are necessary for blood to clot and stop bleeding. They are generated from giant cells called megakaryocytes that reside in the bone marrow, inside bones. When bone marrow is unable to produce enough platelets, the body bruises and bleeds more easily, for example, blood won’t clot when you get a cut, and the chance of internal bleeding during surgery or after a big trauma increases.

Millions of platelet transfusions are needed each year to treat people suffering from hematological diseases, viral infections, or chemotherapy. Today the main source of platelets is from healthy donors and immunological matches are a big issue. Platelet shortage is common when donation rates are down, mainly during summer, or during public health emergencies, such as pandemics.

Platelets cannot be stored for more than a few days and only at room temperature. Given their short shelf lifespan, platelets must be screened for bacteria and viruses quickly and delivered immediately to individuals who need them. This translates into a recurring shortage worldwide.

SilkPlatelet is focused on solving this demand with a novel 3D solution for large-scale ex vivo platelet production by engineering a groundbreaking platform that combines the use of silk biomaterial and modular flow chambers to recreate the environment of the human bone marrow where platelets are produced.

SilkPlatelet can program lab-grown megakaryocytes to believe they are inside a human body and make them produce platelets on-demand, in greater quantities, with better control of quality, safety, and compatibility with recipients than with donor platelets.

As it gets scaled up and industrialized, SilkPlatelet could have systems generating personalized platelets or systems generating universally compatible platelets.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Key developments have been achieved in the first part of the project.

The consortium is optimizing a 3D silk-based biomaterial platform for the large-scale generation of human platelets. The platform addresses therapeutic areas with unmet critical needs such as personalized transfusions, patients with acute hemorrhage due to trauma, obstetrics, surgery or wounded in conflict zones. The consortium is completing the fabrication of 3D-engineered silk models to mimic the human bone marrow microenvironment. As part of the activities necessary to scale up the 3D culture, the consortium is working on the design and fabrication of a big version of the silk bioreactor to culture iPS cells.

In parallel, the consortium is optimizing the efficiency of different GMP cell lines to be differentiated into platelets using GMP-compatible culture conditions. To ascertain cell output and purity the consortium is implementing a range of quality control assays. The cell clones have been quality checked and biobanked.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Throughout Europe, the demand for platelets averages 5 units per 1,000 population per annum, i.e. 2.5 million units per year costing over €375 million. Platelet usage is increasing 10% every year while the supply of platelets is entirely dependent on allogenic donations.

SilkPlatelet is developing novel technologies that do not currently exist for producing human platelet ex-vivo. The successful development and distribution of our platform will offer researchers and clinicians specialized instruments for producing platelets on demand. The potential applications are very far-reaching and could lead to the introduction of this technology in other fields of transfusion medicine.

Our project integrates bioengineering, cell and molecular biology, and clinical expertise. The combination of the complementary expertise of the consortium will foster insight into fundamental models to mimic bone marrow physiology for platelet production with breakthrough applications in clinic.

Finally, in our program, we are also enrolling and supporting the research community by training young actors toward future technological leadership.