NCT03570450RecruitingPhase 1
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1
Regenerative Stem Cell Therapy for Stroke in Europe 1
Source: ClinicalTrials.gov · Last updated 27 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- First submitted
- 18 Apr 2018
- Start date
- 2 Jun 2018
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Stroke
- NCT number
- NCT03570450
- EU CT number
- 2024-518394-34-00
- EudraCT number
- 2017-004243-20
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 95
- From 2 Jun 2018 to the primary completion date, 1 Jul 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon Cedex | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| GHU St Anne Psychiatrie et Neurosciences Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.