StrokePhase 2/3RESSTORENCT02849613
Regenerative Stem Cell Therapy for Stroke in Europe
A Phase 2/3 study testing Adipose Derived Stem Cells in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Adipose Derived Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Sep 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hemispheric ischemic stroke (>1.5cm)
- NIHSS > or = 7
- No craniectomy
- Able to follow a rehabilitation program
- Modified Rankin scale = 0 before stroke onset
Who cannot join
- Coma
- Severe leucoariosis
- Previous stroke
- Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
- History of cancer
- Pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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...).
- Conditions
- Stroke
- Being tested
- Adipose Derived Stem Cells, Vehicle media
- Keywords
- cell therapy, stem cell, transplantation, graft, recovery, repair, stroke, mesenchymal stem cell, regenerative
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Derived Stem CellsOther
Also called ADSC
Vehicle mediaOther
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Adipose derived Stem Cells ADSC | Experimental | ADSC, single IV, 1.106 cells/kg Receives: Other: Adipose Derived Stem Cells |
| Vehicle media | Sham comparator | IV infusion of cell excipients, 1ml/kg Receives: Other: Vehicle media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference of NIHSS (stroke severity score)
Measured: 6 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Not authorized by Regulatory agencies - new protocol phase 1a in progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- 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, Oy Medfiles Ltd, 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, Servicio Gallego de Salud, Pirkanmaa Hospital District, Tampere, Finland, Hospital Vall d'Hebron, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Responsible party
- Sponsor
- Investigators
- Olivier DETANTE, MD PhD, Principal investigator, University Hospital Grenoble-Alpes, FranceExuperio DIEZ TEJEDOR, MD PhD, Principal investigator, La Paz University Hospital, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849613
- Sponsor's protocol ID
- 38RC15.337
- Acronym
- RESSTORE
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Stem Cell Therapy for Stroke in Europe
- ClinicalTrials.gov ID
- NCT02849613
- Acronym / sponsor ID
- RESSTORE / 38RC15.337
- Conditions
- Stroke
- Keywords
- cell therapy, stem cell, transplantation, graft, recovery, repair, stroke, mesenchymal stem cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not authorized by Regulatory agencies - new protocol phase 1a in progress
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- 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, Oy Medfiles Ltd, 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, Servicio Gallego de Salud, Pirkanmaa Hospital District, Tampere, Finland, Hospital Vall d'Hebron, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose derived Stem Cells ADSC | Experimental | Other: Adipose Derived Stem CellsADSC, single IV, 1.106 cells/kg |
| Vehicle media | Sham comparator | Other: Vehicle mediaIV infusion of cell excipients, 1ml/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemispheric ischemic stroke (>1.5cm)
- NIHSS > or = 7
- No craniectomy
- Able to follow a rehabilitation program
- Modified Rankin scale = 0 before stroke onset
Key exclusion criteria (6 listed)
- Coma
- Severe leucoariosis
- Previous stroke
- Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Derived Stem CellsAlso: ADSC | Other | Adipose derived Stem Cells ADSC |
| Vehicle mediaAlso: Placebo | Other | Vehicle media |
Primary outcome
Between-group difference of NIHSS (stroke severity score)
Time frame: 6 months after stroke onset
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Active, not recruitingObservational study
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier DETANTE, MD PhD principal investigator
University Hospital Grenoble-Alpes, France
Exuperio DIEZ TEJEDOR, MD PhD principal investigator
La Paz University Hospital, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adipose Derived Stem Cells in people with Stroke, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference of NIHSS (stroke severity score) (time frame: 6 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.