Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT03570450
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '* Dose escalation from 1.10\\^6 cells/kg to 3.10\\^6 cells/kg (phase 1a, non randomized, open-label);\n* Effect-dose: 3.10\\^6 cells/kg + placebo (phase 1b, randomized, double blind);\n\nPhase Ia: n = 15 patients; Phase Ib: n = 80 patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ia (Toxicity study)', 'timeFrame': '7 days after stroke onset', 'description': 'cell-related serious adverse event'}, {'measure': 'Phase Ib (Dose-effect study)', 'timeFrame': '6 months after stroke onset', 'description': 'modelling the dose-effect'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability', 'timeFrame': 'through study completion (2 years)', 'description': 'Adverse events report and mortality over 2 years'}, {'measure': 'Functionnal recovery', 'timeFrame': 'through study completion (2 years)', 'description': 'NIHSS Evolution (0-42) over 2 years'}, {'measure': 'Post stroke handicap', 'timeFrame': 'through study completion (2 years)', 'description': 'Modified Rankin scale (0-6) over 2 years'}, {'measure': 'Motor recovery', 'timeFrame': 'over 6 months post-stroke', 'description': 'Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke'}, {'measure': 'fMRI recovery', 'timeFrame': 'at 6 months post-stroke', 'description': 'activation fMRI and resting state fMRI at 6 months after stroke'}, {'measure': 'Blood biomarkers for stroke recovery', 'timeFrame': 'at 6 months post-stroke', 'description': 'selection of candidate biomarkers for stroke recovery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cell therapy', 'stem cell', 'transplantation', 'graft', 'recovery', 'repair', 'stroke', 'msesenchymal stem cell', 'regenerative'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).\n\n* Male or female \\> 18-year-old\n* 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\n* 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.\n* NIHSS \\> or equal to 7 including motor score (upper, lower limbs and hand) \\> or equal to 3\n* No decompressive craniectomy procedure planned or performed\n* Patient able to follow a rehabilitation program\n* Modified Rankin scale = 0 before stroke onset\n* Obtained signed informed consent from patient or legally acceptable representative\n* Negative pregnancy test for women of child-bearing age.\n\nNon Inclusion Criteria:\n\nNon-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).\n\n* Contraindication for MRI\n* Coma (score of 2 or more on item 1a of the NIHSS related to awareness)\n* Evidence on neuroimaging (CT or MRI) of a brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, or subarachnoid haemorrhage, or intracerebral parenchymal hematoma (petechial small haemorrhages are NOT a non-inclusion criteria)\n* Severe leucoariosis\n* Previous stroke\n* Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)\n* Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)\n* History of cancer\n* Pre-existing dementia\n* 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\n* Surgical or endovascular procedure planned in the following 3 months\n* Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)\n* Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial\n* Non-membership to a social security scheme\n* Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.'}, 'identificationModule': {'nctId': 'NCT03570450', 'briefTitle': 'Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Regenerative Stem Cell Therapy for Stroke in Europe 1', 'orgStudyIdInfo': {'id': '38RC17.312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adipose derived Stem Cells - 1.10^6cells/kg', 'description': 'ADSC, single, IV, 1.10\\^6cells/kg', 'interventionNames': ['Drug: Adipose derived Stem Cell']}, {'type': 'EXPERIMENTAL', 'label': 'Adipose derived Stem Cells - 2.10^6cells/kg', 'description': 'ADSC, single, IV, 2.10\\^6cells/kg', 'interventionNames': ['Drug: Adipose derived Stem Cell']}, {'type': 'EXPERIMENTAL', 'label': 'Adipose derived Stem Cells - 2,5.10^6cells/kg', 'description': 'ADSC, single, IV, 2,5.10\\^6cells/kg', 'interventionNames': ['Drug: Adipose derived Stem Cell']}, {'type': 'EXPERIMENTAL', 'label': 'Adipose derived Stem Cells - 3.10^6cells/kg', 'description': 'ADSC, single, IV, 3.10\\^6cells/kg', 'interventionNames': ['Drug: Adipose derived Stem Cell']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Adipose derived Stem Cell', 'type': 'DRUG', 'otherNames': ['ADSC'], 'description': '4 doses', 'armGroupLabels': ['Adipose derived Stem Cells - 1.10^6cells/kg', 'Adipose derived Stem Cells - 2,5.10^6cells/kg', 'Adipose derived Stem Cells - 2.10^6cells/kg', 'Adipose derived Stem Cells - 3.10^6cells/kg']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Detante, MD PhD', 'role': 'CONTACT', 'email': 'odetante@chu-grenoble-alpes.fr', 'phone': '04 76 76 57 89', 'phoneExt': '+33'}, {'name': 'Zaza Putkaradze, PharmD', 'role': 'CONTACT', 'email': 'zputkaradze@chu-grenoble.fr', 'phone': '0476767842', 'phoneExt': '+33'}], 'facility': 'CHU Grenoble Aples', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Zaza Putkaradze, PharmD', 'role': 'CONTACT', 'email': 'zputkaradze@chu-grenoble.fr', 'phone': '0476767842', 'phoneExt': '+33'}, {'name': 'Julien Colombat', 'role': 'CONTACT', 'email': 'ArcPromoteur@chu-grenoble.fr', 'phone': '04 76 76 56 09', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Olivier Detante, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Grenoble-Alpes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Horizon 2020 - European Commission', 'class': 'OTHER'}, {'name': 'University Grenoble Alps', 'class': 'OTHER'}, {'name': 'Servicio Madrileño de Salud, Madrid, Spain', 'class': 'OTHER'}, {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, {'name': 'Andaluz Health Service', 'class': 'OTHER_GOV'}, {'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'University of Eastern Finland', 'class': 'OTHER'}, {'name': 'Etablissement Français du Sang', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'Histocell SL, Spain', 'class': 'UNKNOWN'}, {'name': 'Oy Medfiles Ltd', 'class': 'INDUSTRY'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, {'name': 'Association Groupe ESSEC', 'class': 'OTHER'}, {'name': 'NOVADISCOVERY SAS, France', 'class': 'UNKNOWN'}, {'name': 'Finovatis', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León', 'class': 'OTHER'}, {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, {'name': 'Servicio de Salud de Castilla La Mancha, Albacete, Spain', 'class': 'UNKNOWN'}, {'name': 'Servicio Gallego de Salud', 'class': 'OTHER_GOV'}, {'name': 'Pirkanmaa Hospital District, Tampere, Finland', 'class': 'UNKNOWN'}, {'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': "Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta", 'class': 'OTHER'}, {'name': 'CH Sainte-Anne, Paris, France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}