Alzheimer Disease (AD)Phase 1NCT07554872
Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease
A Phase 1 study testing Neural Stem Cell-Derived Exosomes in people with Alzheimer Disease (AD), run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This is an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Neural Stem Cell-Derived Exosomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Dec 2027
- Phase
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or postmenopausal female, aged 50 to 75 years.
- Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia.
- Age at onset ≤65 years.
- CMMS score 5-20
- Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications.
- Primary school education or above and able to complete study-required cognitive assessments.
Show all 13Show fewer
- Hachinski Ischemic Score ≤4.
- GDS-30 total score ≤10.
- Screening brain MRI+DWI+SWI meeting protocol-defined cerebrovascular exclusion thresholds and no major structural abnormalities inconsistent with Alzheimer's disease.
- Positive amyloid pathology confirmed by Aβ-PET at screening or before enrollment.
- Adequate vision and hearing to complete assessments.
- Has a reliable caregiver able to accompany the participant to study visits and provide information for assessments.
- Willing to participate and sign informed consent.
Who cannot join
- Dementia due to causes other than Alzheimer's disease.
- Brain MRI showing any of the following: Fazekas white matter hyperintensity score >2; more than 2 lacunar infarcts >1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities.
- Allergy to stem cell-derived exosomes or PET examination.
- Severe psychiatric disorder or symptoms.
- Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver/kidney dysfunction.
- Elevated tumor markers or tumor history.
Show all 12Show fewer
- Immune-related disease.
- Significant nasal obstruction.
- Serious suicide risk.
- Participation in another clinical trial or stem cell therapy within the past 6 months.
- Any other condition judged inappropriate by the investigator.
- Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.
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
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yue Ling 岳玲, MD, PhD, 18964352661, bellinthemoon@hotmail.com
About this study
Official title: A Phase I, Open-Label, Single-Center, Frequency-Escalation Study of the Safety, Tolerability, and Preliminary Efficacy of Neural Stem Cell-Derived Exosomes in Patients With Moderate-to-Severe Early-Onset Alzheimer's Disease
This is an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. A total of 9 participants will be enrolled in 3 frequency-escalation groups: once every 3 days, once every other day, and once daily, each for 28 days. Participants will undergo screening and baseline assessment, a 28-day treatment period, and follow-up visits at 4, 8, and 24 weeks after the end of treatment.
Read the detailed description
Early-onset moderate-to-severe Alzheimer's disease imposes a substantial burden on patients and families, and there is currently no truly effective treatment capable of reversing the pathological process. Neural stem cell-derived exosomes (NSC-EVs) are considered a promising therapeutic approach because they may have low immunogenicity, the ability to cross the blood-brain barrier, and a more standardized manufacturing pathway than cell-based therapy.
This study is designed as an open-label, single-center, three-group phase I clinical study to explore the safety, tolerability, and preliminary efficacy of intranasal NSC-EVs in patients with moderate-to-severe early-onset Alzheimer's disease. The study uses a 3+3 frequency-escalation design with sentinel-participant monitoring to determine the highest tolerated dosing frequency and to generate preliminary clinical data for future larger-scale studies.
A total of 9 participants are planned for enrollment. Participants will be assigned sequentially to 1 of 3 dosing-frequency groups: low-frequency, medium-frequency, or high-frequency. All groups will receive the same investigational product by intranasal administration for 28 days, with differences only in dosing frequency. The low-frequency group will receive treatment on Days 1, 4, 7, 10, 13, 16, 19, 22, 25, and 28; the medium-frequency group will receive treatment on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27; and the high-frequency group will receive treatment daily from Day 1 through Day 28.
After the 4-week treatment period, participants will enter a follow-up phase with visits scheduled at 4 weeks, 8 weeks, and 24 weeks after the end of treatment. Assessments during treatment and follow-up will include safety monitoring, clinical laboratory testing, cognitive and neuropsychiatric evaluations, and protocol-defined biomarker and imaging assessments as applicable. The primary objective is to evaluate safety and tolerability, while secondary and exploratory objectives include preliminary evaluation of cognitive, behavioral, functional, and biomarker changes over time.
- Conditions
- Alzheimer Disease (AD)
- Being tested
- Neural Stem Cell-Derived Exosomes
- Keywords
- Early-Onset Alzheimer's Disease, Moderate-to-Severe Alzheimer's Disease, Neural Stem Cell-Derived Exosomes, Intranasal Administration, Phase I Clinical Study, Frequency Escalation, Safety, Tolerability
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Stem Cell-Derived ExosomesBiological
Also called NSC-EVs
The investigational product is a neural stem cell-derived exosome preparation administered intranasally. The product specification is 6 × 10^9 particles per 2 mL vial. The product is thawed to room temperature before administration and delivered into both nostrils. The same investigational product is used in all study groups; the groups differ only in dosing frequency.
| Study group | Role | What they receive |
|---|---|---|
| Low-Frequency NSC-EVs | Experimental | Participants receive neural stem cell-derived exosomes by intranasal administration once every 3 days for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the low-frequency group, dosing is scheduled on Days 1, 4, 7, 10, 13, 16, 19, 22, 25, and 28, for a total of 10 doses. Receives: Biological: Neural Stem Cell-Derived Exosomes |
| Medium-Frequency NSC-EVs | Experimental | Participants receive neural stem cell-derived exosomes by intranasal administration every other day for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the medium-frequency group, dosing is scheduled on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27, for a total of 14 doses. Receives: Biological: Neural Stem Cell-Derived Exosomes |
| High-Frequency NSC-EVs | Experimental | Participants receive neural stem cell-derived exosomes by intranasal administration once daily for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the high-frequency group, dosing is scheduled daily from Day 1 through Day 28, for a total of 28 doses. Receives: Biological: Neural Stem Cell-Derived Exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
Number of participants experiencing treatment-related adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Baseline to Week 4
Number of Participants With Treatment-Related Clinical Laboratory Abnormalities
Number of participants with treatment-related clinical laboratory abnormalities during the treatment period.
Measured: Baseline to Week 4
Secondary outcomes (8)
Change in Chinese Mini-Mental Status (CMMS) Score
Cognitive function will be assessed using the Chinese Mini-Mental Status (CMMS), a Chinese-language screening instrument for global cognitive impairment. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Severe Impairment Battery (SIB) Score
Cognitive function will be assessed using the Severe Impairment Battery (SIB), a validated instrument for cognitive function in moderate-to-severe dementia. Total scores range from 0 to 100, with higher scores indicating better cognitive performance.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Neuropsychiatric Inventory (NPI) Score
Neuropsychiatric symptoms will be assessed using the Neuropsychiatric Inventory (NPI), a standardized instrument for behavioral and psychological symptoms in dementia. Total scores range from 0 to 144, with higher scores indicating greater neuropsychiatric symptom burden.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Geriatric Depression Scale (GDS) Score
Depressive symptoms will be assessed using the 30-item Geriatric Depression Scale (GDS-30), a questionnaire designed to assess depressive symptoms in older adults. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a questionnaire that evaluates subjective sleep quality and sleep disturbance. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
Functional ability will be assessed using the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), a caregiver-based instrument used to evaluate daily functioning in patients with Alzheimer's disease. Total scores range from 0 to 78, with higher scores indicating better functional ability.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Zarit Burden Interview (ZBI) Score
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a questionnaire used to evaluate the perceived burden experienced by caregivers. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score
Global dementia severity will be assessed using the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB), which evaluates impairment across multiple cognitive and functional domains. Total scores range from 0 to 18, with higher scores indicating greater dementia severity.
Measured: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startMay 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a sequential, open-label, single-center phase 1 study using a 3+3 frequency-escalation design. Participants are enrolled from the lowest-frequency group to the highest-frequency group. Each group starts with 3 participants, including a sentinel participant, and escalation proceeds only after protocol-defined safety review. Expansion is permitted according to protocol-defined dose-limiting toxicity criteria.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Angecon Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Ling YUE, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554872
- Sponsor's protocol ID
- SMHC-EOAD-NSCEV-2026-01
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Single-Center, Frequency-Escalation Study of the Safety, Tolerability, and Preliminary Efficacy of Neural Stem Cell-Derived Exosomes in Patients With Moderate-to-Severe Early-Onset Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07554872
- Acronym / sponsor ID
- SMHC-EOAD-NSCEV-2026-01
- Conditions
- Alzheimer Disease (AD)
- Keywords
- Early-Onset Alzheimer's Disease, Moderate-to-Severe Alzheimer's Disease, Neural Stem Cell-Derived Exosomes, Intranasal Administration, Phase I Clinical Study, Frequency Escalation, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Angecon Biotechnology Co., Ltd.
- Study start
- May 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Apr 2026 (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 an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. A total of 9 participants will be enrolled in 3 frequency-escalation groups: once every 3 days, once every other day, and once daily, each for 28 days. Participants will undergo screening and baseline assessment, a 28-day treatment period, and follow-up visits at 4, 8, and 24 weeks after the end of treatment.
Detailed description
Early-onset moderate-to-severe Alzheimer's disease imposes a substantial burden on patients and families, and there is currently no truly effective treatment capable of reversing the pathological process. Neural stem cell-derived exosomes (NSC-EVs) are considered a promising therapeutic approach because they may have low immunogenicity, the ability to cross the blood-brain barrier, and a more standardized manufacturing pathway than cell-based therapy.
This study is designed as an open-label, single-center, three-group phase I clinical study to explore the safety, tolerability, and preliminary efficacy of intranasal NSC-EVs in patients with moderate-to-severe early-onset Alzheimer's disease. The study uses a 3+3 frequency-escalation design with sentinel-participant monitoring to determine the highest tolerated dosing frequency and to generate preliminary clinical data for future larger-scale studies.
A total of 9 participants are planned for enrollment. Participants will be assigned sequentially to 1 of 3 dosing-frequency groups: low-frequency, medium-frequency, or high-frequency. All groups will receive the same investigational product by intranasal administration for 28 days, with differences only in dosing frequency. The low-frequency group will receive treatment on Days 1, 4, 7, 10, 13, 16, 19, 22, 25, and 28; the medium-frequency group will receive treatment on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27; and the high-frequency group will receive treatment daily from Day 1 through Day 28.
After the 4-week treatment period, participants will enter a follow-up phase with visits scheduled at 4 weeks, 8 weeks, and 24 weeks after the end of treatment. Assessments during treatment and follow-up will include safety monitoring, clinical laboratory testing, cognitive and neuropsychiatric evaluations, and protocol-defined biomarker and imaging assessments as applicable. The primary objective is to evaluate safety and tolerability, while secondary and exploratory objectives include preliminary evaluation of cognitive, behavioral, functional, and biomarker changes over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a sequential, open-label, single-center phase 1 study using a 3+3 frequency-escalation design. Participants are enrolled from the lowest-frequency group to the highest-frequency group. Each group starts with 3 participants, including a sentinel participant, and escalation proceeds only after protocol-defined safety review. Expansion is permitted according to protocol-defined dose-limiting toxicity criteria.
| Arm | Type | Receives |
|---|---|---|
| Low-Frequency NSC-EVs | Experimental | Biological: Neural Stem Cell-Derived ExosomesParticipants receive neural stem cell-derived exosomes by intranasal administration once every 3 days for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the low-frequency group, dosing is scheduled on Days 1, 4, 7, 10, 13, 16, 19, 22, 25, and 28, for a total of 10 doses. |
| Medium-Frequency NSC-EVs | Experimental | Biological: Neural Stem Cell-Derived ExosomesParticipants receive neural stem cell-derived exosomes by intranasal administration every other day for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the medium-frequency group, dosing is scheduled on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27, for a total of 14 doses. |
| High-Frequency NSC-EVs | Experimental | Biological: Neural Stem Cell-Derived ExosomesParticipants receive neural stem cell-derived exosomes by intranasal administration once daily for 28 days. The single dose is 6 × 10^9 particles administered into both nostrils. In the high-frequency group, dosing is scheduled daily from Day 1 through Day 28, for a total of 28 doses. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or postmenopausal female, aged 50 to 75 years.
- Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia.
- Age at onset ≤65 years.
- CMMS score 5-20
- Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications.
Key exclusion criteria (12 listed)
- Dementia due to causes other than Alzheimer's disease.
- Brain MRI showing any of the following: Fazekas white matter hyperintensity score >2; more than 2 lacunar infarcts >1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities.
- Allergy to stem cell-derived exosomes or PET examination.
- Severe psychiatric disorder or symptoms.
- Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver/kidney dysfunction.
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 |
|---|---|---|
| Neural Stem Cell-Derived ExosomesAlso: NSC-EVsThe investigational product is a neural stem cell-derived exosome preparation administered intranasally. The product specification is 6 × 10^9 particles per 2 mL vial. The product is thawed to room temperature before administration and delivered into both nostrils. The same investigational product is used in all study groups; the groups differ only in dosing frequency. | Biological | High-Frequency NSC-EVs, Low-Frequency NSC-EVs, Medium-Frequency NSC-EVs |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: Baseline to Week 4
Number of participants experiencing treatment-related adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Number of Participants With Treatment-Related Clinical Laboratory Abnormalities
Time frame: Baseline to Week 4
Number of participants with treatment-related clinical laboratory abnormalities during the treatment period.
8 secondary outcomes
Change in Chinese Mini-Mental Status (CMMS) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Severe Impairment Battery (SIB) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Neuropsychiatric Inventory (NPI) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Geriatric Depression Scale (GDS) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Zarit Burden Interview (ZBI) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score
Time frame: Baseline, Week 4 (end of treatment), and 4, 8, and 24 weeks after end of treatment
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 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease (AD)
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 1/2
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
Alzheimer's Disease (AD)
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
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 Phase 1 study testing Neural Stem Cell-Derived Exosomes in people with Alzheimer Disease (AD), run by Shanghai Mental Health Center 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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 15 May 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yue Ling 岳玲, MD, PhD (18017311249, bellinthemoon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events (time frame: Baseline to Week 4). The study lists 2 primary outcomes in all. 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 15 May 2026.