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REgenerative Stem cell therapy for STroke in Europe

Fact Sheet

Reporting

Results

Objective

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, due to motor and cognitive impairments, and secondary health problems affecting not only patients but also their families.
Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life. RESSTORE European multicentre randomised phase IIb will explore, for the first time, the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADMSCs) in 400 stroke patients. Therapeutic effects of ADMSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and novel blood biomarkers. Additionally, the societal value and cost-effectiveness of ADMSCs-based regenerative therapy will be evaluated through health economics and predictive in silico simulations. Complementary ancillary animal studies will support the clinical trial by defining i) if the treatment response can be further enhanced by intensive rehabilitation, ii) the contribution of co-morbidities and iii) the mechanism(s) underlying the therapeutic effect.
The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, modelling, biobanking, economic studies, exploitation and communication plan). RESSTORE will thus surely contribute, together with the workforce trained in the context of the programme, to improve its public and private (SME) competitiveness and increase the attractiveness of Europe as a reference location to develop and clinically assess new innovative therapeutic options for brain diseases.

Programme(s)

H2020-EU.3.1.3. - Treating and managing disease

Topic(s)

PHC-15-2015 - Clinical research on regenerative medicine

Call for proposal

H2020-PHC-2015-single-stage_RTD

See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITE GRENOBLE ALPES

Address

621, Avenue Centrale
38401 Saint Martin D'Heres

France

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 781 937,50

Contact the organisation

UNIVERSITE JOSEPH FOURIER GRENOBLE 1

Address

Avenue Centrale, Domaine Universitaire 621
38041 Grenoble

France

Activity type

Higher or Secondary Education Establishments

Website

Contact the organisation

Participants (28)

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SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 134 600

CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE

France

EU Contribution

€ 182 700

FAKULTNI NEMOCNICE U SV. ANNY V BRNE

Czechia

EU Contribution

€ 20 000

SERVICIO ANDALUZ DE SALUD

Spain

EU Contribution

€ 446 825

UNIVERSITY OF GLASGOW

United Kingdom

EU Contribution

€ 20 000

ITA-SUOMEN YLIOPISTO

Finland

EU Contribution

€ 185 035

ETABLISSEMENT FRANCAIS DU SANG

France

EU Contribution

€ 799 718

TAMPEREEN YLIOPISTO

Finland

EU Contribution

€ 360 791

HISTOCELL SL

Spain

EU Contribution

€ 327 365

OY MEDFILES LTD

Finland

EU Contribution

€ 802 187,50

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

EU Contribution

€ 130 325

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA

Spain

EU Contribution

€ 350 000

HOSPICES CIVILS DE LYON

France

EU Contribution

€ 70 000

ASSOCIATION GROUPE ESSEC

France

EU Contribution

€ 200 000

NOVADISCOVERY

France

EU Contribution

€ 274 375

FINOVATIS

France

EU Contribution

€ 232 000

CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE BESANCON

France

EU Contribution

€ 1 700

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 1 700

CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE

France

EU Contribution

€ 1 700

CHU HOPITAUX DE BORDEAUX

France

EU Contribution

€ 1 700

CHU COTE DE NACRE - CAEN

France

EU Contribution

€ 1 700

FUNDACION INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEON

Spain

EU Contribution

€ 1 700

FUNDACIO PRIVADA INSTITUT DE RECERCA DE L'HOSPITAL DE LA SANTA CREU I SANT PAU

Spain

EU Contribution

€ 1 700

SERVICIO DE SALUD DE CASTILLA LA MANCHA

Spain

EU Contribution

€ 1 700

SERVIZO GALEGO DE SAUDE

Spain

EU Contribution

€ 1 700

FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA

Spain

EU Contribution

€ 1 700

PIRKANMAA HOSPITAL DISTRICT

Finland

EU Contribution

€ 1 700

CENTRE HOSPITALIER SAINTE ANNE DE PARIS

France

EU Contribution

€ 1 700

Project information

RESSTORE

Grant agreement ID: 681044

Project website

Status

Ongoing project

Start date

1 September 2015
End date

31 August 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 6 338 260
EU contribution

€ 6 338 259

Coordinated by:

UNIVERSITE GRENOBLE ALPES

France

Periodic Reporting for period 3 - RESSTORE (REgenerative Stem cell therapy for STroke in Europe)

Reporting period: 2018-03-01 to 2019-08-31

Summary of the context and overall objectives of the project

Stroke is the second leading cause of death in the world population. Stroke affects approximately 6 million people in the European Union, with 1.1 million new cases every year. When not fatal, despite spontaneous recovery, stroke often results in disability (70% of stroke survivors), due to motor and/or cognitive impairments, and secondary health problems affecting not only patients but also their families.
Current treatment options are limited to intravenous thrombolysis, thrombectomy, aspirin, decompressive craniectomy, and management in stroke care units for intensive care and rehabilitation. Effective treatments beyond prevention and acute care are urgently needed. This requires a sophisticated understanding of stroke pathophysiology. It is well-known that stroke effects are not limited to neurons but involve both brain cells and the surrounding extracellular matrix in a “glio-neurovascular niche” that interacts with the peripheral immune system. For these reasons, new therapies should target all these systems rather than narrowly targeting an individual damage process. A promising approach for treatment of stroke is activation of brain repair mechanisms and enhancement of spontaneous functional recovery. The major advantage of cell-based therapies is the extended therapeutic time window up to several weeks or months after the initial insult. This makes the treatment available to a much larger number of stroke patients. Cell-based restorative therapies have emerged as attractive approaches for the treatment of stroke. Transplanted cells, an example of “plastic” biological products, can adapt to different local conditions in damaged brain tissue while not being limited to a unique target. They can act on a wide range of endogenous protective and brain repair processes including immunomodulation, neuronal, vascular and glial remodelling.
Building on emerging preclinical and pilot clinical evidences, RESSTORE project focuses on the clinical assessment of reparative cell therapy to improve stroke recovery and patients’ quality of life. RESSTORE European multicentre randomised trial will explore, for the first time, the safety and efficacy (functional recovery) of intravenous infusion of allogenic adipose tissue derived stem cells (ADSCs) in stroke patients. Therapeutic effects of ADSCs will be assessed in patients using clinical rating scales, multimodal MRI and novel blood biomarkers. Additionally, the societal value and cost-effectiveness of ADSCs-based therapy will be evaluated through health economics and predictive in silico simulations.
Complementary ancillary animal studies support the clinical trial by defining i) if the treatment response can be further enhanced by intensive rehabilitation, ii) the contribution of co-morbidities (diabetes, hypertension) and iii) the mechanism(s) underlying the therapeutic effect.
The European regenerative therapy capacities (France, Spain, Finland, UK and Czech Republic), developed in RESSTORE cover the full value chain: large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the repair mechanisms, modelling, biobanking, economic studies, exploitation and communication plan.

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

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)

RESSTORE Impact overview

Project information

RESSTORE

Grant agreement ID: 681044

Project website

Status

Ongoing project

Start date

1 September 2015
End date

31 August 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 6 338 260
EU contribution

€ 6 338 259

Coordinated by:

UNIVERSITE GRENOBLE ALPES

Project information

RESSTORE

Grant agreement ID: 681044

Project website

Status

Ongoing project

Start date

1 September 2015
End date

31 August 2020

Funded under:

H2020-EU.3.1.3.

Overall budget:

€ 6 338 260
EU contribution

€ 6 338 259

Coordinated by:

UNIVERSITE GRENOBLE ALPES

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Last update: 21 April 2017

Record number: 198791

CORDIS

Objective

Coordinator

Participants (28)

Project information

Periodic Reporting for period 3 - RESSTORE (REgenerative Stem cell therapy for STroke in Europe)

Project information

Deliverables

Publications

Project information

Project information

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CORDIS

Objective

Coordinator

Participants (28)

Project information

Periodic Reporting for period 3 - RESSTORE (REgenerative Stem cell therapy for STroke in Europe)

Project information

Deliverables

Publications

Project information

Project information

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