Clinical trial NCT02849613: Regenerative Stem Cell Therapy for Stroke in Europe
Official title: Regenerative Stem Cell Therapy for Stroke in Europe
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Stroke
Keywords: cell therapy
stem cell
transplantation
graft
recovery
repair
stroke
mesenchymal stem cell
regenerative
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
name: University Grenoble Alps
name: Servicio Madrileño de Salud, Madrid, Spain
name: St. Anne's University Hospital Brno, Czech Republic
name: Andaluz Health Service
name: University of Glasgow
name: University of Eastern Finland
name: Etablissement Français du Sang
name: Tampere University
name: Histocell SL, Spain
name: Oy Medfiles Ltd
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Hospices Civils de Lyon
name: Association Groupe ESSEC
name: NOVADISCOVERY SAS, France
name: Finovatis
name: Centre Hospitalier Universitaire de Besancon
name: Assistance Publique - Hôpitaux de Paris
name: University Hospital, Toulouse
name: University Hospital, Bordeaux
name: University Hospital, Caen
name: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Servicio de Salud de Castilla La Mancha, Albacete, Spain
name: Servicio Gallego de Salud
name: Pirkanmaa Hospital District, Tampere, Finland
name: Hospital Vall d'Hebron
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
First posted: 2016-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, 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.

Detailed description: RESSTORE European multicentre randomised phase IIb will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers.

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, biobanking...).

Eligibility criteria: Inclusion Criteria:

* Hemispheric ischemic stroke (\>1.5cm)
* Inclusion from 1 to 4 days post-stroke
* NIHSS \> or = 7
* No craniectomy
* Able to follow a rehabilitation program
* Modified Rankin scale = 0 before stroke onset

Exclusion Criteria:

* Coma
* Severe leucoariosis
* Previous stroke
* Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
* History of cancer
* Pregnancy, breast feeding

Primary outcomes:
measure: Between-group difference of NIHSS (stroke severity score)
timeFrame: 6 months after stroke onset
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Grenoble Hospital / EFS
Study officials:
affiliation: University Hospital Grenoble-Alpes, France
name: Olivier DETANTE, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Paz University Hospital, Madrid, Spain
name: Exuperio DIEZ TEJEDOR, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: