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SELMA

Financiado

Trial Ready Small Vessel MRI Markers Proof of Concept

Problem: Cerebral small vessel disease (SVD) is a hallmark of serious brain diseases such as acute stroke and dementia. It has a major impact on society, since it affects quality of life of many ageing individuals, and increasing... ver más

30/09/2021

UMC UTRECHT

150K€

Presupuesto del proyecto: 150K€

Líder del proyecto

UNIVERSITAIR MEDISCH CENTRUM UTRECHT No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Ver 2 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2021-09-30

Línea de financiación objetivo El proyecto se financió a través de la siguiente ayuda:

ERC-2018-PoC: ERC Proof of Concept Grant

I+D

Cerrada hace 6 años

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2 Participantes

UMC UTRECHT

149.98K€ | Lider

INOXMIMGRUP

357.92K€ | Participante

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Duración del proyecto: 24 meses Fecha Inicio: 2019-09-05
Fecha Fin: 2021-09-30

Líder del proyecto

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

TRL 4-5

Presupuesto del proyecto 150K€

Descripción del proyecto Problem: Cerebral small vessel disease (SVD) is a hallmark of serious brain diseases such as acute stroke and dementia. It has a major impact on society, since it affects quality of life of many ageing individuals, and increasingly challenges the healthcare resources. Current image-based biomarkers do not reflect SVD itself, but rather macroscopic, irreversible brain damage, secondary to the abnormalities of the small vessels. This greatly hampers development of new drugs as clinical trials lack effective biomarkers directly reflecting SVD. Solution: The SmallVesselMRI ERC project (337333), yielded 7T MRI methods with the potential to offer a paradigm shift in SVD research. We have developed new MRI measures that, for the first time, allow non-invasive assessment of the condition of the small vessels themselves, including blood flow velocity pulsation in small perforating vessels, which informs on vessel stiffness. The current proof-of-concept project ‘trial-ready Small vEsseL MRI MArkers (SELMA) aims to make these novel promising vascular parameters ready for use in phase II/III clinical trials. Our ambition is to bridge the gap between high end imaging research platforms and widespread clinical MRI, in order to enable drug-target engagement studies in clinical trials for newly developed drugs. SELMA will: 1) Port the small-vessel 7T MRI pulse sequences to clinically ubiquitous 3T MRI scanners. 2) Develop a software tool that can provide robust, automated data analysis. 3) Determine the reproducibility of the SELMA biomarkers in a group of 35 healthy individuals with scan-rescan experiments. 4) Provide clinical proof of concept by a pilot study in 15 patients with SVD, measuring the vascular parameters before and after administration of a pharmaceutical agent. Using results of our proof of concept study, we will develop a business plan to approach the pharmaceutical industry to change the paradigm in drug development for SVD treatment.

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