Status:
UNKNOWN
Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Brain lesions in the adult have dramatic consequences, because the spontaneous capacity of the brain to functionally recover is limited. Besides existing rehabilitative therapeutic approaches (e.g. ph...
Detailed Description
Using neural grafts to restore function after lesions of the central nervous system is a challenging strategy. Most of the transplantation experience acquired the last decades was focused on fetal neu...
Eligibility Criteria
Inclusion
- Be between 18 and 75 years old.
- Victim of a first ischemic stroke in superficial Sylvian territory with at least frontal damage.
- Cerebral ischemic lesion demonstrated by MRI.
- Stroke older than one year.
- Presence of a motor hemi-syndrome with at least one involvement of the upper limb.
- Stable neurological deficit in motor function of the limb greater than two months apart before enrolling the patient in the study.
- Woman of childbearing potential with a negative blood pregnancy test before the biopsy and using a reliable method of contraception during the study.
- Patient capable of discernment and of giving informed consent himself.
- Absence of other serious pathologies or comorbidities.
Exclusion
- Brain lesions or a history of stroke or brain hemorrhage.
- Signs of peripheral neurological damage, such as radicular or trunk involvement
- History of spinal cord problems.
- History of neurosurgical intervention in the brain.
- surgical intervention contraindications.
- Anticoagulation, if it cannot be interrupted one week before and one week after each of the 2 brain surgeries.
- Coagulation disorders.
- Treatment of botulinum toxin during the last 3 months before inclusion.
- Seizures or anti-epileptic treatment.
- Global cognitive disorders, such as degenerative or vascular dementia.
- High blood pressure difficult to control.
- Alcohol or drug abuse.
- Known neoplasia.
- Inability to understand or cooperate in the study.
- MRI contraindication
- Pregnancy
- Penicillin intolerance or allergy
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04488965
Start Date
December 1 2020
End Date
September 1 2025
Last Update
November 3 2020
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011