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Trial record 2 of 2 for:    "RESSTORE"

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

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Adipose derived Stem Cell Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Regenerative Stem Cell Therapy for Stroke in Europe 1
Actual Study Start Date : June 2, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Adipose derived Stem Cells - 1.10^6cells/kg
ADSC, single, IV, 1.10^6cells/kg
Drug: Adipose derived Stem Cell
3 doses
Other Name: ADSC

Experimental: Adipose derived Stem Cells - 2.10^6cells/kg
ADSC, single, IV, 2.10^6cells/kg
Drug: Adipose derived Stem Cell
3 doses
Other Name: ADSC

Experimental: Adipose derived Stem Cells - 2,5.10^6cells/kg
ADSC, single, IV, 2,5.10^6cells/kg
Drug: Adipose derived Stem Cell
3 doses
Other Name: ADSC

Experimental: Adipose derived Stem Cells - 3.10^6cells/kg
ADSC, single, IV, 3.10^6cells/kg
Drug: Adipose derived Stem Cell
3 doses
Other Name: ADSC

Placebo Comparator: placebo
Placebo
Drug: placebo
placebo




Primary Outcome Measures :
  1. Phase Ia (Toxicity study) [ Time Frame: 7 days after stroke onset ]
    cell-related serious adverse event

  2. Phase Ib (Dose-effect study) [ Time Frame: 6 months after stroke onset ]
    modelling the dose-effect


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: through study completion (2 years) ]
    Adverse events report and mortality over 2 years

  2. Functionnal recovery [ Time Frame: through study completion (2 years) ]
    NIHSS Evolution (0-42) over 2 years

  3. Post stroke handicap [ Time Frame: through study completion (2 years) ]
    Modified Rankin scale (0-6) over 2 years

  4. Motor recovery [ Time Frame: over 6 months post-stroke ]
    Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke

  5. fMRI recovery [ Time Frame: at 6 months post-stroke ]
    activation fMRI and resting state fMRI at 6 months after stroke

  6. Blood biomarkers for stroke recovery [ Time Frame: at 6 months post-stroke ]
    selection of candidate biomarkers for stroke recovery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570450


Contacts
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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

Locations
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France
CHU Recruiting
Grenoble, France, 38043
Contact: Olivier Detante, MD PhD    04 76 76 57 89 ext +33    odetante@chu-grenoble-alpes.fr   
Contact: Laetitia Wioland, PhD    04 76 76 57 89 ext +33    lwioland@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
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
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Principal Investigator: Olivier Detante, MD PhD University Hospital Grenoble-Alpes

Additional Information:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03570450     History of Changes
Other Study ID Numbers: 38RC17.312
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Cell therapy
stem cell
transplantation
graft
recovery
repair
stroke
msesenchymal stem cell
regenerative
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases