Regenerative Stem Cell Therapy for Stroke in Europe "RESSTORE"

Recruiting

Phase 2/3 Results N/A

Trial Description

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

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...).

Conditions

Interventions

  • Adipose Derived Stem Cells Other
    Other Names: ADSC
    ARM 1: Kind: Experimental
    Label: Adipose derived Stem Cells ADSC
    Description: ADSC, single IV, 1.106 cells/kg
  • Vehicle media Other
    Other Names: Placebo
    ARM 1: Kind: Experimental
    Label: Vehicle media
    Description: IV infusion of cell excipients, 1ml/kg

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Between-group difference of NIHSS (stroke severity score) 6 months after stroke onset No

Sponsors