Actively Recruiting
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
Led by University Hospital, Grenoble · Updated on 2023-07-27
95
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
H
Horizon 2020 - European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female older than 18 years
- Hemispheric ischemic stroke larger than 1.5 cm on at least 2 imaging slices
- Admitted to stroke unit within 24 hours after stroke onset
- Ability to be included and randomized between 24 and 48 hours after stroke onset
- Able to receive investigational treatment within the first week after stroke
- NIHSS score of 7 or higher including motor score of 3 or higher
- No decompressive craniectomy planned or performed
- Able to follow a rehabilitation program
- Modified Rankin scale of 0 before stroke onset
- Signed informed consent obtained from patient or legal representative
- Negative pregnancy test for women of child-bearing age
You will not qualify if you...
- Contraindication for MRI
- Coma with a score of 2 or more on NIHSS item 1a related to awareness
- Brain tumor, cerebral edema with midline shift, significant ventricle compression, cerebellar or brainstem infarction, subarachnoid hemorrhage, or intracerebral hematoma on imaging
- Severe leukoaraiosis
- Previous stroke
- Active endocarditis, pneumonia, AIDS, or active hepatic disease due to HBV or HCV (except controlled infection)
- Active inflammatory or autoimmune diseases such as Crohn's disease, lupus, rheumatoid arthritis, renal or liver immune pathology
- History of cancer
- Pre-existing dementia
- Clinical condition or health status preventing diagnosis, treatment, or follow-up
- Planned surgical or endovascular procedure within 3 months
- Pregnancy or breastfeeding
- Participation in another therapeutic or biotherapy trial
- Non-membership to a social security scheme
- Inability or unwillingness to provide written informed consent according to national regulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Grenoble Aples
Grenoble, France, 38043
Actively Recruiting
Research Team
Z
Zaza Putkaradze, PharmD
CONTACT
J
Julien Colombat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here