Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1

NCT03570450 | Recruiting Phase 1 DMC

• 1 other identifier: 38RC17.312
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cell therapy; stem cell; transplantation; graft; recovery; repair; stroke; msesenchymal stem cell; regenerative

Outcome Measures

Primary Outcomes (2)

• Phase Ia (Toxicity study)

  cell-related serious adverse event

  7 days after stroke onset

• Phase Ib (Dose-effect study)

  modelling the dose-effect

  6 months after stroke onset

Secondary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability

  through study completion (2 years)

• Functionnal recovery

  through study completion (2 years)

• Post stroke handicap

  through study completion (2 years)

• Motor recovery

  over 6 months post-stroke

• fMRI recovery

  at 6 months post-stroke

Study Arms (5)

Adipose derived Stem Cells - 1.10^6cells/kg

EXPERIMENTAL

ADSC, single, IV, 1.10\^6cells/kg

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 2.10^6cells/kg

EXPERIMENTAL

ADSC, single, IV, 2.10\^6cells/kg

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 2,5.10^6cells/kg

EXPERIMENTAL

ADSC, single, IV, 2,5.10\^6cells/kg

Drug: Adipose derived Stem Cell

Adipose derived Stem Cells - 3.10^6cells/kg

EXPERIMENTAL

ADSC, single, IV, 3.10\^6cells/kg

Drug: Adipose derived Stem Cell

placebo

PLACEBO COMPARATOR

Placebo

Other: placebo

Interventions

Adipose derived Stem Cell DRUG

4 doses

Also known as: ADSC

Adipose derived Stem Cells - 1.10^6cells/kg; Adipose derived Stem Cells - 2,5.10^6cells/kg; Adipose derived Stem Cells - 2.10^6cells/kg; Adipose derived Stem Cells - 3.10^6cells/kg

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18-year-old
• Hemispheric ischemic stroke (\> 1.5 cm on 2 imaging slices) (i.e. non "lacunar" stroke) Admitted to the stroke unit within the first 24h after stroke onset
• Patient must be included within 1st and 2nd day after stroke onset (signature of informed consent and randomization) (i.e. between 24 hours and 48 hours from stroke onset) and must be able to receive investigation treatment within the first week.
• NIHSS \> or equal to 7 including motor score (upper, lower limbs and hand) \> or equal to 3
• No decompressive craniectomy procedure planned or performed
• Patient able to follow a rehabilitation program
• Modified Rankin scale = 0 before stroke onset
• Obtained signed informed consent from patient or legally acceptable representative
• Negative pregnancy test for women of child-bearing age.
• Contraindication for MRI
• Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
• Severe leucoariosis
• Previous stroke
• Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)
• History of cancer

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Horizon 2020 - European Commission: collaborator
• University Grenoble Alps: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator
• St. Anne's University Hospital Brno, Czech Republic: collaborator
• Andaluz Health Service: collaborator
• University of Glasgow: collaborator
• University of Eastern Finland: collaborator
• Etablissement Français du Sang: collaborator
• Tampere University: collaborator
• Histocell SL, Spain: collaborator
• Oy Medfiles Ltd: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Hospices Civils de Lyon: collaborator
• Association Groupe ESSEC: collaborator
• NOVADISCOVERY SAS, France: collaborator
• Finovatis: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Bordeaux: collaborator
• University Hospital, Caen: collaborator
• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Servicio de Salud de Castilla La Mancha, Albacete, Spain: collaborator
• Servicio Gallego de Salud: collaborator
• Pirkanmaa Hospital District, Tampere, Finland: collaborator
• Hospital Vall d'Hebron: collaborator
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: collaborator
• CH Sainte-Anne, Paris, France: collaborator

Study Sites (1)

CHU Grenoble Aples

Grenoble, 38043, France

RECRUITING

Related Publications (1)

• Legris L, Moisan A, Jaillard A, Bonnet L, Moulin T, Sibon I, Touze E, Favre-Wiki I, Cordonnier C, Dellaschiava L, Mazighi M, Rosso C, Alamowitch S, Calvet D, Barbieux-Guillot M, Roux S, Mojallal AA, Boucher F, Thuriot A, Soulard J, Naegele B, Perennou D, Roustit M, Putkaradze Z, Hommel M, Lehmann A, Colombat J, Chorfa F, Maucort-Boulch D, Lamalle L, Grand S, Krainik A, Detante O. Regenerative stem cell therapy for stroke in Europe (RESSTORE): a multicenter randomized controlled efficacy clinical trial. Front Stroke. 2024 Sep 27;3:1416490. doi: 10.3389/fstro.2024.1416490. eCollection 2024.

  PMID: 41542240 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier Detante, MD PhD

  University Hospital Grenoble-Alpes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaza Putkaradze, PharmD

CONTACT

0476767842; zputkaradze@chu-grenoble.fr

Julien Colombat

CONTACT

04 76 76 56 09; ArcPromoteur@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Dose escalation from 1.10\^6 cells/kg to 3.10\^6 cells/kg (phase 1a, non randomized, open-label); * Effect-dose: 3.10\^6 cells/kg + placebo (phase 1b, randomized, double blind); Phase Ia: n = 15 patients; Phase Ib: n = 80 patients

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 27, 2018
• Study Start: June 2, 2018
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

FR (1)