Regenerative Stem Cell Therapy for Stroke in Europe

Stroke Clinical Trial

— RESSTORE  

Official title:

Regenerative Stem Cell Therapy for Stroke in Europe

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02849613
• Other study ID #: 38RC15.337
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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...).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Adipose Derived Stem Cells

• Vehicle media

Locations

Country	Name	City	State
France	University Grenoble Hospital / EFS	Grenoble

Sponsors (29)

Lead Sponsor

Collaborator

University Hospital, Grenoble

Andaluz Health Service, Assistance Publique - Hôpitaux de Paris, Association Groupe ESSEC, Centre Hospitalier Universitaire de Besancon, Etablissement Français du Sang, Finovatis, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León, Histocell SL, Spain, Horizon 2020 - European Commission, Hospices Civils de Lyon, Hospital Vall d'Hebron, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Institut National de la Santé Et de la Recherche Médicale, France, Medfiles CRO, Finland, NOVADISCOVERY SAS, France, Pirkanmaa Hospital District, Tampere, Finland, Servicio de Salud de Castilla La Mancha, Albacete, Spain, Servicio Madrileño de Salud, Madrid, Spain, Servizo Galego de Saude, Santiago de Compostela, Spain, St. Anne's University Hospital Brno, Czech Republic, Tampere University, University Grenoble Alps, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Toulouse, University of Eastern Finland, University of Glasgow

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group difference of NIHSS (stroke severity score)		6 months after stroke onset