Ischemic StrokeAVCellNCT04488965
Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia
A study testing Autologous transplant in people with Ischemic Stroke, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Autologous transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Jocelyne Bloch, MD, +41 21 314 12 93, jocelyne.bloch@chuv.ch
About this study
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.
Read the 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 neuronal grafts. However, despite the great enthusiasm generated by this approach, ethical controversies, immune rejection, and lack of fetal donors remain a major problem. Therefore, autotransplantation of adult brain cells represents an attractive restoration alternative to bypass the caveats of fetal grafting.
The optimization of the procedure to obtain ANCE, a cortical autograft obtained from cortical biopsy, was first successfully demonstrated in producing long-term primary culture of adult human brain cells from temporal lobe tissues obtained from epilepsy and trauma neurosurgical patients. ANCE has been characterized as an ecosystem of autologous neural cells in suspension, composed of several cell types: astrocytes, proliferative progenitors and quiescent progenitors.
The production of ANCE has been implemented to prepare long-term primary culture from primate cortical biopsies. This allowed assessing the feasibility of autotransplantation from brain biopsy to reimplantation of cultured brain cells in a non-human primate model of motor cortex lesion. On the same model of cerebral cortex lesion in nonhuman primates, further study demonstrated, by quantitative behavioral evidence, the beneficial outcome of cell therapy following injury of the cerebral cortex.
Based on the encouraging results from past experiences on non-human primate model of motor cortex lesion, this monocentric pilot study aims at evaluating the feasibility and safety of ANCE (Autologous Neural Cell Ecosystems), which is cortical autograft intended to be used on stroke patients, for the replacement of motor neurons destroyed during an ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- Autologous transplant
- Keywords
- autologous transplant, brain cell therapy, motor cortex lesion, cortical autograft
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous transplantOther
Autologous transplant obtained from cortical biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Autologous transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
CBS is an observational, functional, performance based assessment, being 0 (indicating no neglect) to 30 (indicating severe neglect).
Measured: 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
NIHSS quantifies the impairment caused by a stroke, being 0 no stroke symptoms, and 42 severe impairment.
Measured: 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
The Modified Rankin Scale measures the degree of disability or dependence in the daily activities, being 0 no symptoms, 5 severe disability and 6 dead.
Measured: 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)
ARAT assesses upper limb functioning using observational methods (19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement)), being 0 incapability to perform the test, and 57 being able to perform the test normally.
Measured: 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)
BBT measures unilateral gross manual dexterity. The BBT is composed of a box divided in two compartments by a partition and 150 blocks. Participants are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores are indicative of better manual dexterity.
Measured: 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 Resistance to passive movement scale (Repas)
Assessed for the upper limb and lower limb (maximum score being 56 and 48, respectively, being 0 no increase in muscle tone and the maximum score increased resistance to passive movement (affected part rigid in flexion or extension).
Measured: 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 Activities of Daily Living (ADL)
Activities of Daily Living (ADLs) are tasks related to personal care: for each task the score varies from 7 when completely independent, to 1 when requiring total support. Hence, higher scores are indicative of better functional independence.
Measured: 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 Rivermead Mobility Index
The Rivermead Mobility Index is a measure of disability related to bodily mobility. It demonstrates the patient's ability to move her or his own body, being 0 the lowest score and 15 the highest. The highest the score the better the mobility.
Measured: 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 Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 predetermined tasks. Score ranges from 0 to 4 for each task, being the highest total score 56, i.e. completely independent.
Measured: 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 London Handicap Scale (LHS)
The London Handicap Scale can be used to determine the effect of chronic disorders on a person's functional ability using a self-completion questionnaire. Minimum scale value is 0 and maximum is 1, with 1 indicating normal function.
Measured: up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric, non-randomized, open-label with single-arm design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488965
- Sponsor's protocol ID
- AVCell2020
- Acronym
- AVCell
- Status last verified
- Nov 2020
- First submitted
- 2 Jun 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Effects of Cortical Autograft Implantation in Patients With Cerebral Ischemia
- ClinicalTrials.gov ID
- NCT04488965
- Acronym / sponsor ID
- AVCell / AVCell2020
- Conditions
- Ischemic Stroke
- Keywords
- autologous transplant, brain cell therapy, motor cortex lesion, cortical autograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 neuronal grafts. However, despite the great enthusiasm generated by this approach, ethical controversies, immune rejection, and lack of fetal donors remain a major problem. Therefore, autotransplantation of adult brain cells represents an attractive restoration alternative to bypass the caveats of fetal grafting.
The optimization of the procedure to obtain ANCE, a cortical autograft obtained from cortical biopsy, was first successfully demonstrated in producing long-term primary culture of adult human brain cells from temporal lobe tissues obtained from epilepsy and trauma neurosurgical patients. ANCE has been characterized as an ecosystem of autologous neural cells in suspension, composed of several cell types: astrocytes, proliferative progenitors and quiescent progenitors.
The production of ANCE has been implemented to prepare long-term primary culture from primate cortical biopsies. This allowed assessing the feasibility of autotransplantation from brain biopsy to reimplantation of cultured brain cells in a non-human primate model of motor cortex lesion. On the same model of cerebral cortex lesion in nonhuman primates, further study demonstrated, by quantitative behavioral evidence, the beneficial outcome of cell therapy following injury of the cerebral cortex.
Based on the encouraging results from past experiences on non-human primate model of motor cortex lesion, this monocentric pilot study aims at evaluating the feasibility and safety of ANCE (Autologous Neural Cell Ecosystems), which is cortical autograft intended to be used on stroke patients, for the replacement of motor neurons destroyed during an ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric, non-randomized, open-label with single-arm design
| Arm | Type | Receives |
|---|---|---|
| Autologous neural cell ecosystems - ANCE | Experimental | Other: Autologous transplantThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous transplantAutologous transplant obtained from cortical biopsy | Other | Autologous neural cell ecosystems - ANCE |
Primary outcome
Assess the feasibility and safety of ANCE treatment by evaluating the incidence of treatment-related adverse events
Time frame: 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)
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.
10 secondary outcomes
Change in the medium term of the participant score when assessing the "Catherine Bergego Scale" (CBS)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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 Resistance to passive movement scale (Repas)
Time frame: 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 Activities of Daily Living (ADL)
Time frame: 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 Rivermead Mobility Index
Time frame: 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 Berg Balance Scale
Time frame: 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 London Handicap Scale (LHS)
Time frame: up to 54 months (Assessment is performed at each visit up to the last visit 4 years after reimplantation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous transplant in people with Ischemic Stroke, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne Bloch, Pr MD (+41795562951, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility and safety of ANCE treatment by evaluating the incidence of treatment-related adverse events (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.