Trial | NCT02849613  Report issue

Official Title

Regenerative Stem Cell Therapy for Stroke in Europe

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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...).
Study Started
Mar 31
2016
Primary Completion
Sep 30
2017
Study Completion
Sep 30
2017
Last Update
Oct 06
2021

Other Adipose Derived Stem Cells

  • Other names: ADSC

Other Vehicle media

  • Other names: Placebo

Adipose derived Stem Cells ADSC Experimental

ADSC, single IV, 1.106 cells/kg

Vehicle media Sham Comparator

IV infusion of cell excipients, 1ml/kg

Criteria 

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
No Results Posted