Project description
Targeted, secure bioactive therapy thanks to gel delivery system
Fistulas are relatively common abnormal, tunnel-like connections between one internal organ and another, or between an organ and the skin surface. They are a complication of Crohn's disease, often occurring between the vagina and rectum or the intestine and the skin. The use of extracellular vesicles (EVs) secreted by stem cells rather than the use of the stem cells themselves to promote tissue regeneration could have many benefits all along the supply and use chain, yet it has met numerous technical challenges. The EU-funded ExocyTher project plans to overcome them with reliable large-scale EV production and an optimised EV delivery system, which will exploit a medically cleared gel delivery device to assist in filling the entire fistula tract and keeping the EVs in place.
Objective
Extracellular vesicles (EVs) from stem cells (SCs) may recapitulate the therapeutic effect of their mother cells in regenerative medicine while mitigating risks of uncontrolled replication, differentiation and vascular occlusion, offering off-the-shelf, storage and shelf-life gains. Yet, the clinical translation of SC EV therapy is hampered by production, engineering and administration challenges.
Building on my preliminary results, ExocyTher aims at developing SC EV therapy through:
(1) standardized scalable high-yield EV production: I propose the concept of turbulence vesiculation to induce EV release from adipose SCs (ASCs) by a controlled turbulence shear stress integrated to large-scale cell culture in bioreactors;
(2) optimised delivery: I propose EV administration in a synergic fistula-occlusive companion gel (injectable at <20C and gelling at body temperature) in the attempt to fill the entire fistula tract and retain EVs at the site of interest;
ExocyTher will tackle the therapy of fistulas, a major health burden related to Crohn's disease or secondary to surgery, cancer therapy or trauma, affecting millions of people in Europe with a high morbidity rate. All-in-one turbulence-triggered vesiculation and priming are expected to provide ASC EVs in high yield and with improved immunomodulatory properties specially for a more efficient therapy of inflammatory Crohns disease fistulas. Capitalizing on the use of a gel medical device authorized in Europe as an off-label fistula occlusive EV vehicle and considering key regulatory issues, ExocyTher will set the basis for the first clinical trial on ASC EV fistula therapy.
ExocyTher concepts may be extended to other EV parent cell types or therapy indications, foreseeing a high scientific and technological impact.
Start date is requested due to the COVID-19 pandemic and this is necessary to minimise any disruption could be caused by the COVID-19 pandemic.
Fields of science (EuroSciVoc)
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CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.1.1. - EXCELLENT SCIENCE - European Research Council (ERC)
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Call for proposal
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(opens in new window) ERC-2019-STG
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75794 PARIS
France
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