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Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)

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ClinicalTrials.gov Identifier: NCT02849613
Recruitment Status : Withdrawn (Not authorized by Regulatory agencies - new protocol phase 1a in progress)
First Posted : July 29, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
Horizon 2020 - European Commission
University Grenoble Alps
Servicio Madrileño de Salud, Madrid, Spain
St. Anne's University Hospital Brno, Czech Republic
Andaluz Health Service
University of Glasgow
University of Eastern Finland
Etablissement Français du Sang
Tampere University
Histocell SL, Spain
Medfiles CRO, Finland
Institut National de la Santé Et de la Recherche Médicale, France
Hospices Civils de Lyon
Association Groupe ESSEC
NOVADISCOVERY SAS, France
Finovatis
Centre Hospitalier Universitaire de Besancon
Assistance Publique - Hôpitaux de Paris
University Hospital, Toulouse
University Hospital, Bordeaux
University Hospital, Caen
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
Servicio de Salud de Castilla La Mancha, Albacete, Spain
Servizo Galego de Saude, Santiago de Compostela, Spain
Pirkanmaa Hospital District, Tampere, Finland
Hospital Vall d'Hebron
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Adipose Derived Stem Cells Other: Vehicle media Phase 2 Phase 3

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...).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regenerative Stem Cell Therapy for Stroke in Europe
Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Adipose derived Stem Cells ADSC
ADSC, single IV, 1.106 cells/kg
Other: Adipose Derived Stem Cells
Other Name: ADSC

Sham Comparator: Vehicle media
IV infusion of cell excipients, 1ml/kg
Other: Vehicle media
Other Name: Placebo




Primary Outcome Measures :
  1. Between-group difference of NIHSS (stroke severity score) [ Time Frame: 6 months after stroke onset ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849613


Locations
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France
University Grenoble Hospital / EFS
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Horizon 2020 - European Commission
University Grenoble Alps
Servicio Madrileño de Salud, Madrid, Spain
St. Anne's University Hospital Brno, Czech Republic
Andaluz Health Service
University of Glasgow
University of Eastern Finland
Etablissement Français du Sang
Tampere University
Histocell SL, Spain
Medfiles CRO, Finland
Institut National de la Santé Et de la Recherche Médicale, France
Hospices Civils de Lyon
Association Groupe ESSEC
NOVADISCOVERY SAS, France
Finovatis
Centre Hospitalier Universitaire de Besancon
Assistance Publique - Hôpitaux de Paris
University Hospital, Toulouse
University Hospital, Bordeaux
University Hospital, Caen
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
Servicio de Salud de Castilla La Mancha, Albacete, Spain
Servizo Galego de Saude, Santiago de Compostela, Spain
Pirkanmaa Hospital District, Tampere, Finland
Hospital Vall d'Hebron
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Investigators
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Principal Investigator: Olivier DETANTE, MD PhD University Hospital Grenoble-Alpes, France
Principal Investigator: Exuperio DIEZ TEJEDOR, MD PhD La Paz University Hospital, Madrid, Spain

Additional Information:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02849613     History of Changes
Other Study ID Numbers: 38RC15.337
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Grenoble:
cell therapy
stem cell
transplantation
graft
recovery
repair
stroke
mesenchymal stem cell
regenerative

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases