Regenerative stem cell therapy for stroke recovery
Regenerative Stem Cell Therapy for Stroke in Europe 1
This study is testing whether a new treatment using stem cells from fat can help people recover better after having a stroke.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT03570450 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of adipose-derived stem cells to enhance recovery in patients who have suffered a hemispheric ischemic stroke. Participants will receive either the stem cell treatment or a placebo within 24 to 48 hours after stroke onset, with the aim of assessing the safety and efficacy of the therapy. The study focuses on improving patients' quality of life and functional recovery through innovative regenerative medicine approaches. It is designed as a Phase 1 trial to evaluate initial responses and potential benefits of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced a hemispheric ischemic stroke and meet specific clinical criteria.
Not a fit: Patients who have undergone decompressive craniectomy or have a modified Rankin scale score greater than 0 before the stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve recovery outcomes and quality of life for stroke patients.
How similar studies have performed: Other studies exploring stem cell therapies for stroke have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grenoble
- CHU Grenoble Aples — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Olivier Detante, MD PhD — University Hospital Grenoble-Alpes
- Study coordinator: Zaza Putkaradze, PharmD
- Email: zputkaradze@chu-grenoble.fr
- Phone: 0476767842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.