Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1

Stroke Clinical Trial

Official title:

Regenerative Stem Cell Therapy for Stroke in Europe 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570450
• Other study ID #: 38RC17.312
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2, 2018
• Est. completion date: July 1, 2027

Study information

• Verified date: July 2023
• Source: University Hospital, Grenoble
• Contact: Zaza Putkaradze, PharmD
• Phone: 0476767842
• Email: zputkaradze[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).

• 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.

Non Inclusion Criteria:

Non-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).

• Contraindication for MRI

• Coma (score of 2 or more on item 1a of the NIHSS related to awareness)

• Evidence on neuroimaging (CT or MRI) of a brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, or subarachnoid haemorrhage, or intracerebral parenchymal hematoma (petechial small haemorrhages are NOT a non-inclusion criteria)

• Severe leucoariosis

• Previous stroke

• Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)

• Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)

• History of cancer

• Pre-existing dementia

• A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial

• Surgical or endovascular procedure planned in the following 3 months

• Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)

• Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial

• Non-membership to a social security scheme

• Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Adipose derived Stem Cell
4 doses

Other:
• placebo
placebo

Locations

Country	Name	City	State
France	CHU Grenoble Aples	Grenoble

Sponsors (30)

Lead Sponsor

Collaborator

University Hospital, Grenoble

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Ia (Toxicity study)	cell-related serious adverse event	7 days after stroke onset
Primary	Phase Ib (Dose-effect study)	modelling the dose-effect	6 months after stroke onset
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability	Adverse events report and mortality over 2 years	through study completion (2 years)
Secondary	Functionnal recovery	NIHSS Evolution (0-42) over 2 years	through study completion (2 years)
Secondary	Post stroke handicap	Modified Rankin scale (0-6) over 2 years	through study completion (2 years)
Secondary	Motor recovery	Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke	over 6 months post-stroke
Secondary	fMRI recovery	activation fMRI and resting state fMRI at 6 months after stroke	at 6 months post-stroke
Secondary	Blood biomarkers for stroke recovery	selection of candidate biomarkers for stroke recovery	at 6 months post-stroke