Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
- Conditions
- Stroke
- Interventions
- Drug: Adipose derived Stem CellOther: placebo
- Registration Number
- NCT03570450
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 95
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- 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 Ib (Dose-effect study) 6 months after stroke onset modelling the dose-effect
Phase Ia (Toxicity study) 7 days after stroke onset cell-related serious adverse event
- 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
Trial Locations
- Locations (1)
CHU Grenoble Aples
🇫🇷Grenoble, France