Ischemic StrokeEarly Phase 1NXL-001NCT06761183
Safety and Preliminary Efficacy of NXL-001 in Patients With Ischemic Stroke
A Early Phase 1 study testing intracerebral stereotactic injection of NXL-001 in people with Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a single-arm, open-label, single center, dose-escalation exploratory clinical study to evaluate the safety and tolerability of a single intracerebral injection of NXL-001, a NeuroD1 base gene therapy, in patients with chronic neuronal deficits from ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- intracerebral stereotactic injection of NXL-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-75 years, inclusive, gender is not limited.
- Clinical diagnosis of ischemic stroke confirmed by neuro-imaging（CT , MRI，et al）.
- 2-12 months after the onset of ischemic stroke.
- MRI scan shows that the stroke lesion is 20-80ml in size, with cerebral motor cortex injury, and DTI shows corticospinal tract injury.
- Persisting moderate to severe motor function impairment due to stroke after standardized and guide-recommended rehabilitation therapy, characterized by baseline NIHSS score of 6-20 points, and a motor score of 2-4 on the affected upper or lower limb.
- Expected survival ≥ 12 months.
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- The patient or his/her legal representative clearly understands, voluntarily participates in the study and signs the informed consent form.
- The subject is willing and able to return for follow-up visits as required by the trial protocol.
- Able to undergo rehabilitation training and treatment;
- Male and female subjects participating in the clinical study must agree to use an adequate birth control method for at least 6 months after administration
Who cannot join
- Motor deficit due to ischemic stroke of posterior circulation.
- Motor deficit due to any other causes.
- History of epilepsy.
- History of encephalitis, meningitis, multiple sclerosis or other central nervous system infections.
- History of intracranial hemorrhage and subarachnoid hemorrhage.
- History of severe head trauma within the past 5 years.
Show all 19Show fewer
- Any contraindications to MRI scanning (such as implanted pacemaker, infusion pump etc.).
- Serum anti-AAV9 antibody titers ≥ 1:1000
- History of malignant tumors within 5 years before screening (except for adequately treated cervical carcinoma in situ, papillary thyroid cancer, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ).
- Active infections, including but not limited to human immunodeficiency virus (HIV), hepatitis A, B or C, syphilis, etc.
- Received any investigational drugs within 3 months (or 5 half-lives of the investigational drug, whichever is longer) of initial screening.
- Received any other cell and/or gene therapy for stroke.
- Requirement for anticoagulants.
- Intermittent use of oral anti-spasticity medications (stop/start date from 1-month prior-to and 3-month post- NXL-001 administration). Use of oral anti-spasticity medications are acceptable if they have been taken regularly for at least one month prior to NXL-001 administration).
- Pregnant or lactating female subjects.
- Insufficient reserved functions of liver, kidney and bone marrow: Neutrophil count <1,500/mm 3 ; platelets <100, 000/mm 3 ; hemoglobin <9.0 g/dL; serum creatinine >1.5 times the upper limit of normal range (ULN) ; renal function eGFR < 60mL/min/ 1.73m2 ; Bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 times ULN; activated partial prothrombin time ( APTT ) or international normalized ratio ( INR ) >1.3 times ULN.
- Poorly controlled illness judged by the investigator at screening, including cardiovascular system (decompensated heart failure (NYHA classification III and IV), unstable angina, acute myocardial infarction), Respiratory system, digestive system, endocrine metabolic system, neuropsychiatric system, blood system and immune system diseases, etc.
- Based on medical history and investigator's judgment, the subject is at significant risk of suicide.
- In the investigator's judgment, the subject has any other factors deemed inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 10070
Zhu Yahui, +8613439182912, zhuyahuidr@sina.com
About this study
This is a single-arm, open-label, single center, dose-escalation exploratory clinical study to evaluate the safety and tolerability of a single intracerebral injection of NXL-001, a NeuroD1 base gene therapy, in patients with chronic neuronal deficits from ischemic stroke.
Read the detailed description
The death of neurons after stroke is the direct cause of brain function loss, and the difficulty of neurons to regenerate themselves in the adult brain is an important reason for the lack of effective treatment for stroke. Replacing the lost neurons and then reconstructing the functional connectivity between neurons is the key to improving stroke symptoms. NXL-001 is a gene therapy, using an AAV9 (adeno-associated virus 9) vector to deliver and express the neurodevelopmental transcription factor NeuroD1 to directly convert astrocytes into functional neurons. NXL-001 has been shown to regenerate neurons and improve motor function when administered in animal models of stroke. The primary objective of this single-arm, open-label, single center, dose-escalation study is to evaluate the safety and tolerability of intracerebral stereotactic injection of NXL-001. The secondary objective is to preliminarily evaluate the efficacy of NXL-001 in patients with chronic neuronal deficits from ischemic stroke and to determine its safe and effective dose range. This dose escalation study involves three cohorts, with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
- Conditions
- Ischemic Stroke
- Being tested
- intracerebral stereotactic injection of NXL-001
- Keywords
- Ischemic Stroke, Gene therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracerebral stereotactic injection of NXL-001Genetic
intracerebral stereotactic injection of NXL-001: with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
| Study group | Role | What they receive |
|---|---|---|
| intracerebral stereotactic injection of NXL-001 | Experimental | intracerebral stereotactic injection of NXL-001: with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses. Receives: Genetic: intracerebral stereotactic injection of NXL-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of NXL-001
Incidence of adverse events (AE) and serious adverse events (SAE) according to CTCAE 5.0
Measured: baseline to month 3 after dose
Secondary outcomes (11)
Change in MRI images from baseline at month 12
Changes in MRI images of cerebral infarction areas before and after treatment
Measured: Baseline (Screening), and on day 7, month 1,3,6 and 12 after dose
Change in PET images from baseline at month 12
Changes in PET images will be used to assess metabolic changes in the infarct and its surrounding area before and after treatment
Measured: Baseline (Screening), and at month 3 and 12 after dose
Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score from baseline to month 12
The NIHSS is a standardized method used to measure the level of impairment caused by a stroke. The scale consists of 11 items that measure several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each impairment uncovered during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke with 0=no stroke, 1-4=minor stroke, 5-15=moderate stroke, 15-20=moderate/severe stroke, and 21-42=severe stroke.
Measured: Baseline (Screening), and on day1, 7, and at month 1,3,6 and 12 after dose
Change in the Modified Rankin Scale (mRS) Response from Baseline to Month 12
The mRS is a commonly used scale for measuring the degree of disability in daily activities for patients who have suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.
Measured: Baseline (Screening), and on day1, 7, and at month 1,3,6 and 12 after dose
Change in the Fugl-Meyer Assessment (FMA) from Baseline to Month 12
The FMA is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in upper and lower limbs, reflex activity, volitional movement, and coordination.The Fugl-Meyer motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance), and is comprised of a 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items are summed to determine scores for the 2 subscale scores, as well as a motor total score (total of the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. A maximally affected person will have a score of 0 while a fully functional person will have the highest score (i.e., 34 for LE-FMMS, 66 for UE-FMMS, 100 for FMM)
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the modified Ashworth Scale from baseline to month 12
The Modified Ashworth Scale (MAS) is the most commonly used clinical scale to measure hypertonic or spastic muscle. The scale ranges from 0 to 4, with the muscle acting across the joint rated based on what point during flexion or extension resistance or a catch is noted. A score of 0 indicates no resistance to passive movement, with a 4 indicating a rigid joint.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the gait function scale from baseline to month 12
The gait function scale consists of 4 items that measure several aspects of gait function quantitatively and semi-quantitatively, including balance, Six-meter Walk test, Tandem walking test, and Quick sit-up test.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Action Research Arm Test (ARAT) from baseline to month 12
The Action Research Arm Test (ARAT) is a 19-item observational measure to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Each item is rated 4 (0-3 points), 0 = no movement；1= movement task is partially performed；2 = movement task is completed but takes abnormally long；3 = movement is performed normally. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the EQ-5D-5L scale from baseline to month 12
The EQ-5D, EuroQol Five Dimensions Questionnaire, is a set of standardized scales measuring health status. The EQ-5D-5L descriptive system consists of five dimensions (each describing a specific aspect of health): mobility, self-care, daily activities, pain or discomfort, anxiety or depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Electroencephalogram（EEG）from baseline to month 12
EEG is a simple, low-cost, non-invasive tool that can provide information about the changes occurring in the cerebral cortex during the recovery process after stroke. EEG provides data on the evolution of cortical activation patterns.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Motor-evoked potential (MEP) from baseline to month 12
Motor evoked potential (MEP) amplitude and threshold are predictors of functional outcome in the early stages after stroke, and improvement in these parameters usually accompanies motor recovery.
Measured: Baseline (Screening), and at month 1,3,6 and 12 after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start31 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- intracerebral stereotactic injection of NXL-001：with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761183
- Sponsor's protocol ID
- KY2024-378-02
- Acronym
- NXL-001
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma NX, Puls B, Chen G. Transcriptomic analyses of NeuroD1-mediated astrocyte-to-neuron conversion. Dev Neurobiol. 2022 Jul;82(5):375-391. doi: 10.1002/dneu.22882. Epub 2022 May 23.
PubMed 35606902Kuwabara T, Hsieh J, Muotri A, Yeo G, Warashina M, Lie DC, Moore L, Nakashima K, Asashima M, Gage FH. Wnt-mediated activation of NeuroD1 and retro-elements during adult neurogenesis. Nat Neurosci. 2009 Sep;12(9):1097-105. doi: 10.1038/nn.2360. Epub 2009 Aug 23.
PubMed 19701198Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.
PubMed 30878104Zerna C, Hegedus J, Hill MD. Evolving Treatments for Acute Ischemic Stroke. Circ Res. 2016 Apr 29;118(9):1425-42. doi: 10.1161/CIRCRESAHA.116.307005.
PubMed 27126651Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
PubMed 31248666
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of NXL-001 in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06761183
- Acronym / sponsor ID
- NXL-001 / KY2024-378-02
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Gene therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
This is a single-arm, open-label, single center, dose-escalation exploratory clinical study to evaluate the safety and tolerability of a single intracerebral injection of NXL-001, a NeuroD1 base gene therapy, in patients with chronic neuronal deficits from ischemic stroke.
Detailed description
The death of neurons after stroke is the direct cause of brain function loss, and the difficulty of neurons to regenerate themselves in the adult brain is an important reason for the lack of effective treatment for stroke. Replacing the lost neurons and then reconstructing the functional connectivity between neurons is the key to improving stroke symptoms. NXL-001 is a gene therapy, using an AAV9 (adeno-associated virus 9) vector to deliver and express the neurodevelopmental transcription factor NeuroD1 to directly convert astrocytes into functional neurons. NXL-001 has been shown to regenerate neurons and improve motor function when administered in animal models of stroke. The primary objective of this single-arm, open-label, single center, dose-escalation study is to evaluate the safety and tolerability of intracerebral stereotactic injection of NXL-001. The secondary objective is to preliminarily evaluate the efficacy of NXL-001 in patients with chronic neuronal deficits from ischemic stroke and to determine its safe and effective dose range. This dose escalation study involves three cohorts, with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intracerebral stereotactic injection of NXL-001：with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses.
| Arm | Type | Receives |
|---|---|---|
| intracerebral stereotactic injection of NXL-001 | Experimental | Genetic: intracerebral stereotactic injection of NXL-001intracerebral stereotactic injection of NXL-001: with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40-75 years, inclusive, gender is not limited.
- Clinical diagnosis of ischemic stroke confirmed by neuro-imaging（CT , MRI，et al）.
- 2-12 months after the onset of ischemic stroke.
- MRI scan shows that the stroke lesion is 20-80ml in size, with cerebral motor cortex injury, and DTI shows corticospinal tract injury.
- Persisting moderate to severe motor function impairment due to stroke after standardized and guide-recommended rehabilitation therapy, characterized by baseline NIHSS score of 6-20 points, and a motor score of 2-4 on the affected upper or lower limb.
Key exclusion criteria (19 listed)
- Motor deficit due to ischemic stroke of posterior circulation.
- Motor deficit due to any other causes.
- History of epilepsy.
- History of encephalitis, meningitis, multiple sclerosis or other central nervous system infections.
- History of intracranial hemorrhage and subarachnoid hemorrhage.
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 |
|---|---|---|
| intracerebral stereotactic injection of NXL-001intracerebral stereotactic injection of NXL-001: with 3 subjects in each group to receive a single stereo-tactically intracerebral injection of NXL-001 at escalating doses. | Genetic | intracerebral stereotactic injection of NXL-001 |
Primary outcome
Safety and tolerability of NXL-001
Time frame: baseline to month 3 after dose
Incidence of adverse events (AE) and serious adverse events (SAE) according to CTCAE 5.0
11 secondary outcomes
Change in MRI images from baseline at month 12
Time frame: Baseline (Screening), and on day 7, month 1,3,6 and 12 after dose
Change in PET images from baseline at month 12
Time frame: Baseline (Screening), and at month 3 and 12 after dose
Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score from baseline to month 12
Time frame: Baseline (Screening), and on day1, 7, and at month 1,3,6 and 12 after dose
Change in the Modified Rankin Scale (mRS) Response from Baseline to Month 12
Time frame: Baseline (Screening), and on day1, 7, and at month 1,3,6 and 12 after dose
Change in the Fugl-Meyer Assessment (FMA) from Baseline to Month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the modified Ashworth Scale from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the gait function scale from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Action Research Arm Test (ARAT) from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the EQ-5D-5L scale from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Electroencephalogram（EEG）from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Change in the Motor-evoked potential (MEP) from baseline to month 12
Time frame: Baseline (Screening), and at month 1,3,6 and 12 after dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 35606902Ma NX, Puls B, Chen G. Transcriptomic analyses of NeuroD1-mediated astrocyte-to-neuron conversion. Dev Neurobiol. 2022 Jul;82(5):375-391. doi: 10.1002/dneu.22882. Epub 2022 May 23.
- Background: PubMed 19701198Kuwabara T, Hsieh J, Muotri A, Yeo G, Warashina M, Lie DC, Moore L, Nakashima K, Asashima M, Gage FH. Wnt-mediated activation of NeuroD1 and retro-elements during adult neurogenesis. Nat Neurosci. 2009 Sep;12(9):1097-105. doi: 10.1038/nn.2360. Epub 2009 Aug 23.
- Background: PubMed 30878104Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.
- Background: PubMed 27126651Zerna C, Hegedus J, Hill MD. Evolving Treatments for Acute Ischemic Stroke. Circ Res. 2016 Apr 29;118(9):1425-42. doi: 10.1161/CIRCRESAHA.116.307005.
- Background: PubMed 31248666Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intracerebral stereotactic injection of NXL-001 in people with Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
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 10 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhu Yahui, MD (0086-13439182912, zhuyahuidr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of NXL-001 (time frame: baseline to month 3 after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761183, which also lists 5 linked publications.
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 9 Sep 2026.