Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)
Status and phase
Conditions
Treatments
Details and patient eligibility
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.
Full description
RESSTORE European multicentre randomised phase IIb will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers.
The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, biobanking...).
Sex
Ages
Volunteers
Inclusion criteria
- Hemispheric ischemic stroke (>1.5cm)
- Inclusion from 1 to 4 days post-stroke
- NIHSS > or = 7
- No craniectomy
- Able to follow a rehabilitation program
- Modified Rankin scale = 0 before stroke onset
Exclusion criteria
- Coma
- Severe leucoariosis
- Previous stroke
- Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
- History of cancer
- Pregnancy, breast feeding
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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