Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
NCT ID: NCT03570450
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
95 participants
INTERVENTIONAL
2018-06-02
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
* Effect-dose: 3.10\^6 cells/kg + placebo (phase 1b, randomized, double blind);
Phase Ia: n = 15 patients; Phase Ib: n = 80 patients
TREATMENT
DOUBLE
Study Groups
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Adipose derived Stem Cells - 1.10^6cells/kg
ADSC, single, IV, 1.10\^6cells/kg
Adipose derived Stem Cell
4 doses
Adipose derived Stem Cells - 2.10^6cells/kg
ADSC, single, IV, 2.10\^6cells/kg
Adipose derived Stem Cell
4 doses
Adipose derived Stem Cells - 2,5.10^6cells/kg
ADSC, single, IV, 2,5.10\^6cells/kg
Adipose derived Stem Cell
4 doses
Adipose derived Stem Cells - 3.10^6cells/kg
ADSC, single, IV, 3.10\^6cells/kg
Adipose derived Stem Cell
4 doses
placebo
Placebo
placebo
placebo
Interventions
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Adipose derived Stem Cell
4 doses
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemispheric ischemic stroke (\> 1.5 cm on 2 imaging slices) (i.e. non "lacunar" stroke) Admitted to the stroke unit within the first 24h after stroke onset
* Patient must be included within 1st and 2nd day after stroke onset (signature of informed consent and randomization) (i.e. between 24 hours and 48 hours from stroke onset) and must be able to receive investigation treatment within the first week.
* NIHSS \> or equal to 7 including motor score (upper, lower limbs and hand) \> or equal to 3
* No decompressive craniectomy procedure planned or performed
* Patient able to follow a rehabilitation program
* Modified Rankin scale = 0 before stroke onset
* Obtained signed informed consent from patient or legally acceptable representative
* Negative pregnancy test for women of child-bearing age.
* Contraindication for MRI
* Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
* Severe leucoariosis
* Previous stroke
* Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)
* History of cancer
* Pre-existing dementia
* A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial
* Surgical or endovascular procedure planned in the following 3 months
* Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)
* Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial
* Non-membership to a social security scheme
* Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.
18 Years
ALL
No
Sponsors
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Horizon 2020 - European Commission
OTHER
University Grenoble Alps
OTHER
Servicio Madrileño de Salud, Madrid, Spain
OTHER
St. Anne's University Hospital Brno, Czech Republic
OTHER
Andaluz Health Service
OTHER_GOV
University of Glasgow
OTHER
University of Eastern Finland
OTHER
Etablissement Français du Sang
OTHER
Tampere University
OTHER
Histocell SL, Spain
UNKNOWN
Oy Medfiles Ltd
INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Hospices Civils de Lyon
OTHER
Association Groupe ESSEC
OTHER
NOVADISCOVERY SAS, France
UNKNOWN
Finovatis
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
University Hospital, Toulouse
OTHER
University Hospital, Bordeaux
OTHER
University Hospital, Caen
OTHER
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Servicio de Salud de Castilla La Mancha, Albacete, Spain
UNKNOWN
Servicio Gallego de Salud
OTHER_GOV
Pirkanmaa Hospital District, Tampere, Finland
UNKNOWN
Hospital Vall d'Hebron
OTHER
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
CH Sainte-Anne, Paris, France
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Olivier Detante, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Grenoble-Alpes
Locations
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CHU Grenoble Aples
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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38RC17.312
Identifier Type: -
Identifier Source: org_study_id
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