drugset / Trial / NCT03570450
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
Phase 1
Recruiting
95 enrolled
University Hospital, Grenoble
Andaluz Health Service · collabAssistance Publique - Hôpitaux de Paris · collabAssociation Groupe ESSEC · collabCH Sainte-Anne, Paris, France · collabCentre Hospitalier Universitaire de Besancon · collabEtablissement Français du Sang · collabFinovatis · collabFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · collabFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · collabHistocell SL, Spain · collabHorizon 2020 - European Commission · collabHospices Civils de Lyon · collabHospital Vall d'Hebron · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta · collabNOVADISCOVERY SAS, France · collabOy Medfiles Ltd · collabPirkanmaa Hospital District, Tampere, Finland · collabServicio Gallego de Salud · collabServicio Madrileño de Salud, Madrid, Spain · collabServicio de Salud de Castilla La Mancha, Albacete, Spain · collabSt. Anne's University Hospital Brno, Czech Republic · collabTampere University · collabUniversity Grenoble Alps · collabUniversity Hospital, Bordeaux · collabUniversity Hospital, Caen · collabUniversity Hospital, Toulouse · collabUniversity of Eastern Finland · collabUniversity of Glasgow · collab
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2018-06-02
- Primary completion
- 2025-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adipose derived Stem Cell | Cell therapy | 1.1e+06 cells/kg | Intravenous |
| Subject | Adipose derived Stem Cell | Cell therapy | 2.1e+06 cells/kg | Intravenous |
| Subject | Adipose derived Stem Cell | Cell therapy | 2.5e+06 cells/kg | Intravenous |
| Subject | Adipose derived Stem Cell | Cell therapy | 3.1e+06 cells/kg | Intravenous |