Regenerative Stem Cell Therapy for Stroke in Europe 1

Phase 1

Not yet recruiting

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.

Recruitment & 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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Adipose derived Stem Cells - 3.10^6cells/kg	Adipose derived Stem Cell	ADSC, single, IV, 3.10\^6cells/kg
placebo	placebo	Placebo
Adipose derived Stem Cells - 1.10^6cells/kg	Adipose derived Stem Cell	ADSC, single, IV, 1.10\^6cells/kg
Adipose derived Stem Cells - 2,5.10^6cells/kg	Adipose derived Stem Cell	ADSC, single, IV, 2,5.10\^6cells/kg
Adipose derived Stem Cells - 2.10^6cells/kg	Adipose derived Stem Cell	ADSC, single, IV, 2.10\^6cells/kg

Primary Outcome Measures

Name	Time	Method
Phase Ia (Toxicity study)	7 days after stroke onset	cell-related serious adverse event
Phase Ib (Dose-effect study)	6 months after stroke onset	modelling the dose-effect

Secondary Outcome Measures

Name	Time	Method
fMRI recovery	at 6 months post-stroke	activation fMRI and resting state fMRI at 6 months after stroke
Functionnal recovery	through study completion (2 years)	NIHSS Evolution (0-42) over 2 years
Post stroke handicap	through study completion (2 years)	Modified Rankin scale (0-6) over 2 years
Motor recovery	over 6 months post-stroke	Fugl Meyer score (0-226) assessed by physiotherapist over 6 months post-stroke
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability	through study completion (2 years)	Adverse events report and mortality over 2 years
Blood biomarkers for stroke recovery	at 6 months post-stroke	selection of candidate biomarkers for stroke recovery

Locations (6): Hopitaux Universitaires Pitie Salpetriere
🇫🇷
Paris Cedex 13, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Bordeaux, France
CHU de Besançon
🇫🇷
Besançon Cedex, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille Cedex, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
GHU St Anne Psychiatrie et Neurosciences
🇫🇷
Paris, France
Hopitaux Universitaires Pitie Salpetriere
🇫🇷Paris Cedex 13, France
Charlotte ROSSO
Site contact
0142161854
charlotte.rosso@aphp.fr