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Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)

Primary Purpose

Stroke

Status
Withdrawn
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Adipose Derived Stem Cells
Vehicle media
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cell therapy, stem cell, transplantation, graft, recovery, repair, stroke, mesenchymal stem cell, regenerative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Grenoble Hospital / EFS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Adipose derived Stem Cells ADSC

Vehicle media

Arm Description

ADSC, single IV, 1.106 cells/kg

IV infusion of cell excipients, 1ml/kg

Outcomes

Primary Outcome Measures

Between-group difference of NIHSS (stroke severity score)

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
September 28, 2021
Sponsor
University Hospital, Grenoble
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
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1. Study Identification

Unique Protocol Identification Number
NCT02849613
Brief Title
Regenerative Stem Cell Therapy for Stroke in Europe
Acronym
RESSTORE
Official Title
Regenerative Stem Cell Therapy for Stroke in Europe
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Not authorized by Regulatory agencies - new protocol phase 1a in progress
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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...).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cell therapy, stem cell, transplantation, graft, recovery, repair, stroke, mesenchymal stem cell, regenerative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adipose derived Stem Cells ADSC
Arm Type
Experimental
Arm Description
ADSC, single IV, 1.106 cells/kg
Arm Title
Vehicle media
Arm Type
Sham Comparator
Arm Description
IV infusion of cell excipients, 1ml/kg
Intervention Type
Other
Intervention Name(s)
Adipose Derived Stem Cells
Other Intervention Name(s)
ADSC
Intervention Type
Other
Intervention Name(s)
Vehicle media
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Between-group difference of NIHSS (stroke severity score)
Time Frame
6 months after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier DETANTE, MD PhD
Organizational Affiliation
University Hospital Grenoble-Alpes, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Exuperio DIEZ TEJEDOR, MD PhD
Organizational Affiliation
La Paz University Hospital, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Grenoble Hospital / EFS
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Regenerative Stem Cell Therapy for Stroke in Europe

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