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Regenerative Stem Cell Therapy for Stroke in Europe 1 ( ) (RESSTORE 1)

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ClinicalTrials.gov Identifier: NCT03570450
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : June 27, 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
CH Sainte-Anne, Paris, France
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE June 27, 2018
Last Update Posted Date June 27, 2018
Actual Study Start Date  ICMJE June 2, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Phase Ia (Toxicity study) [ Time Frame: 7 days after stroke onset ]
    cell-related serious adverse event
  • Phase Ib (Dose-effect study) [ Time Frame: 6 months after stroke onset ]
    modelling the dose-effect
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: through study completion (2 years) ]
    Adverse events report and mortality over 2 years
  • Functionnal recovery [ Time Frame: through study completion (2 years) ]
    NIHSS Evolution (0-42) over 2 years
  • Post stroke handicap [ Time Frame: through study completion (2 years) ]
    Modified Rankin scale (0-6) over 2 years
  • Motor recovery [ Time Frame: over 6 months post-stroke ]
    Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke
  • fMRI recovery [ Time Frame: at 6 months post-stroke ]
    activation fMRI and resting state fMRI at 6 months after stroke
  • Blood biomarkers for stroke recovery [ Time Frame: at 6 months post-stroke ]
    selection of candidate biomarkers for stroke recovery
Original Secondary Outcome Measures  ICMJE Same as current
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 1 ( )
Official Title  ICMJE Regenerative Stem Cell Therapy for Stroke in Europe 1
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation from 1.10^6 cells/kg to 3.10^6 cells/kg (phase 1a,non randomized) Effect-dose: 3 doses from the phase 1a + placebo (phase 1b, randomized)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: Adipose derived Stem Cell
    3 doses
    Other Name: ADSC
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: Adipose derived Stem Cells - 1.10^6cells/kg
    ADSC, single, IV, 1.10^6cells/kg
    Intervention: Drug: Adipose derived Stem Cell
  • Experimental: Adipose derived Stem Cells - 2.10^6cells/kg
    ADSC, single, IV, 2.10^6cells/kg
    Intervention: Drug: Adipose derived Stem Cell
  • Experimental: Adipose derived Stem Cells - 2,5.10^6cells/kg
    ADSC, single, IV, 2,5.10^6cells/kg
    Intervention: Drug: Adipose derived Stem Cell
  • Experimental: Adipose derived Stem Cells - 3.10^6cells/kg
    ADSC, single, IV, 3.10^6cells/kg
    Intervention: Drug: Adipose derived Stem Cell
  • Placebo Comparator: placebo
    Placebo
    Intervention: Drug: placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).

  • Male or female > 18-year-old
  • 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.

Non Inclusion Criteria:

Non-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).

  • Contraindication for MRI
  • Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
  • 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)
  • Severe leucoariosis
  • Previous stroke
  • Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)
  • 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.
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: Claire Bollart 04 76 76 59 57 ext +33 ArcPromoteur@chu-grenoble.fr
Contact: laetitia wioland, PhD 04 76 76 57 89 ext +33 lwioland@chu-grenoble.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03570450
Other Study ID Numbers  ICMJE 38RC17.312
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
  • CH Sainte-Anne, Paris, France
Investigators  ICMJE
Principal Investigator: Olivier Detante, MD PhD University Hospital Grenoble-Alpes
PRS Account University Hospital, Grenoble
Verification Date December 2017

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