Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Other: Adipose Derived Stem Cells; Other: Vehicle media

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...).

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University Grenoble Hospital / EFS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adipose derived Stem Cells ADSC; ADSC, single IV, 1.106 cells/kg	Other: Adipose Derived Stem Cells; Other Names: ADSC
Sham Comparator: Vehicle media; IV infusion of cell excipients, 1ml/kg	Other: Vehicle media; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Between-group difference of NIHSS (stroke severity score)	6 months after stroke onset

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stroke; recovery; cell therapy; stem cell; transplantation; mesenchymal stem cell; graft; repair; regenerative
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 38RC15.337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided