Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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Recruitment Status : Withdrawn (Not authorized by Regulatory agencies - new protocol phase 1a in progress)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

Tracking Information
First Submitted Date  ICMJE July 6, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date January 5, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
Between-group difference of NIHSS (stroke severity score) [ Time Frame: 6 months after stroke onset ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02849613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regenerative Stem Cell Therapy for Stroke in Europe
Official Title  ICMJE Regenerative Stem Cell Therapy for Stroke in Europe
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...).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: Adipose Derived Stem Cells
    Other Name: ADSC
  • Other: Vehicle media
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Adipose derived Stem Cells ADSC
    ADSC, single IV, 1.106 cells/kg
    Intervention: Other: Adipose Derived Stem Cells
  • Sham Comparator: Vehicle media
    IV infusion of cell excipients, 1ml/kg
    Intervention: Other: Vehicle media
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 4, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
400
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849613
Other Study ID Numbers  ICMJE 38RC15.337
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Olivier DETANTE, MD PhD University Hospital Grenoble-Alpes, France
Principal Investigator: Exuperio DIEZ TEJEDOR, MD PhD La Paz University Hospital, Madrid, Spain
PRS Account University Hospital, Grenoble
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP