Regenerative Stem Cell Therapy for Stroke in Europe

Phase 2

Withdrawn

• Conditions: Stroke
• Interventions: Other: Vehicle media; Other: Adipose Derived Stem Cells

• Registration Number: NCT02849613
• Lead Sponsor: 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.

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...).

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle media	Vehicle media	IV infusion of cell excipients, 1ml/kg
Adipose derived Stem Cells ADSC	Adipose Derived Stem Cells	ADSC, single IV, 1.106 cells/kg

Primary Outcome Measures

Name	Time	Method
Between-group difference of NIHSS (stroke severity score)	6 months after stroke onset

Trial Locations

Locations (1)

University Grenoble Hospital / EFS; 🇫🇷 Grenoble, France