Regenerative stem cell therapy for stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

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• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.