Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia

NCT04488965 | Unknown

• 1 other identifier: AVCell2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. physiotherapy), several lines of research aim at developing treatments to promote and refine brain plasticity to enhance functional recovery following brain injury. This pilot clinical study aims at enrolling subjects victim of a stroke with neuronal destruction leading to a disabling motor deficit. Usually these patients benefit from intensive neurorehabilitation which allows them to progress up to a certain point but when their recovery plateau is reached; current medicine is disarmed and no effective treatment allows, to date, to improve further their performance. This monocentric pilot study aims at evaluating the feasibility and safety of Autologous Neural Cell Ecosystems (ANCE), which is a cortical autograft intended to be used on stroke patients, for the replacement of motor neurons destroyed during an ischemic stroke.

Conditions

Ischemic Stroke

Keywords

autologous transplant; brain cell therapy; motor cortex lesion; cortical autograft

Outcome Measures

Primary Outcomes (1)

• Assess the feasibility and safety of ANCE treatment by evaluating the incidence of treatment-related adverse events

  Successful collection of the cortical biopsy; in vitro production of the cortical autograft from the cortical biopsy; and reimplantation of the transplant without treatment-related serious adverse events.

  54 months (Visits will be carried out 2 years and 4 years after reimplantation in order to ensure that there is no long-term complication of ANCE reimplantation)

Secondary Outcomes (10)

• Change in the medium term of the participant score when assessing the "Catherine Bergego Scale" (CBS)

  up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)

• Change in the medium term of the participant score when assessing the NIHSS

  up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)

• Change in the medium term of the participant score when assessing the Modified Rankin Scale

  up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)

• Change in the medium term of the patient score when assessing the Action Research Arm Test (ARAT)

  up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)

• Change in the medium term of the patient score when assessing the Box and Block Test (BBT)

  up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)

Study Arms (1)

Autologous neural cell ecosystems - ANCE

EXPERIMENTAL

The patient will undergo first surgery under general anesthesia for the collection of the cortical biopsy (5x5x5 mm biopsy of non-dominant frontal cortex). After the production of ANCE from the cortical biopsy, which last 8 to 12 weeks, the patient will undergo a second neurosurgery, for the stereotaxic reimplantation of ANCE under general anesthesia.

Other: Autologous transplant

Interventions

Autologous transplant OTHER

Autologous transplant obtained from cortical biopsy

Autologous neural cell ecosystems - ANCE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Jocelyne Bloch, Pr MD

CONTACT

+41795562951; jocelyne.bloch@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: monocentric, non-randomized, open-label with single-arm design

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: July 28, 2020
• Study Start: December 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

CH (1)