A Phase 1 interventional study of hUC-MSC-sEV-001 nasal drops in Alzheimer Disease, Parkinson Disease and Lewy Body Dementia, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Xuanwu Hospital, Beijing · Phase 1, Interventional, and Treatment
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Among 26 studies in Alzheimer Disease by Xuanwu Hospital, Beijing — 19 open to participants now, 20 under way, 1 of them phase 3. Alzheimer Disease · Xuanwu Hospital, Beijing.
Among the 26 studies in Alzheimer Disease by Xuanwu Hospital, Beijing, this one is the 6th largest by planned enrollment of the 19 interventional ones that give a count, is one of 8 that started in 2025, is one of 4 in phase 1, reaches primary completion later than 10 of the 19 other live ones, and was the 14th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →19 of the 26 studies in Alzheimer Disease by Xuanwu Hospital, Beijing are open now, in 1 country. Recruiting first, the newest first:
Xuanwu Hospital, Beijing · Sites in China
Ages 50+
Xuanwu Hospital, Beijing · Sites in China
Ages 50+ · Healthy volunteers
Xuanwu Hospital, Beijing · Sites in China
Ages 50–90
Xuanwu Hospital, Beijing · Sites in China
Ages 60–80
Xuanwu Hospital, Beijing · Sites in China
Ages 50–90
By country, each count listing its studies:
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 1 · Phase 3 1
First in 2016; this study’s year is marked. 8 started in 2025.
This study's planned enrollment of 120 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 40 across the 19 interventional studies, 2,300 across the 7 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Xuanwu Hospital, Beijing is the lead sponsor of 364 studies on the registry; 230 are open to participants now.
5 of the studies in Alzheimer Disease by Xuanwu Hospital, Beijing that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07323914Phase 3Xuanwu Hospital, BeijingClinical Analgesic Management in Dementia | 2027-01-01 |
| NCT07323927Xuanwu Hospital, BeijingInvestigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease | 2027-01-01 |
| NCT07208734Xuanwu Hospital, BeijingPersonalized Brain Stimulation for Cognitive Impairment in Older Adults | 2027-06-01 |
| NCT06607900Xuanwu Hospital, BeijinghUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases | 2027-08-31 |
| NCT07230158Xuanwu Hospital, BeijingTranscranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II) | 2027-09-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 26 studies in Alzheimer Disease by Xuanwu Hospital, Beijing, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To evaluate the safety and preliminary efficacy of human umbilical cord mesenchymal stem cell-derived small extracellular vesicles hUC-MSC-sEV-001 nasal drops in multiple neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, multiple system atrophy, Lewy body dementia, frontotemporal dementia, and amyotrophic lateral sclerosis.
General Criteria:
Inclusion Criteria:
Exclusion Criteria:
Alzheimer's Disease (AD) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
Parkinson's Disease (PD) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
1. Parkinsonism other than PD, including but not limited to progressive supranuclear palsy (PSP), multiple system atrophy (MSA), vascular parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia.
Multiple System Atrophy (MSA) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
Dementia with Lewy Bodies (DLB) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
Frontotemporal Dementia (FTD) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
1. Diagnosis of severe central nervous system diseases other than FTD that may be the cause of the patient's FTD symptoms or may affect the study objectives.
Amyotrophic Lateral Sclerosis (ALS) Specific Criteria:
Inclusion Criteria:
Exclusion Criteria:
1. Diagnosis of non-ALS patients based on clinical presentation and available auxiliary clinical examinations (neurophysiology, MRI or other imaging techniques, laboratory tests, etc.).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
hUC-MSC-sEV-001 nasal drops treatment
Drug: hUC-MSC-sEV-001 nasal drops
hUC-MSC-sEV-001 nasal drops
Alzheimer's disease: Change in Alzheimer's disease assessment scale-cognitive section（ADAS-cog）
ADAS-Cog is comprised of 11 modalities that evaluate memory, praxis, and language deficiencies. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment.
Time frame: 12 months
Parkinson's disease: Change in MDS Unified-Parkinson Disease Rating Scale(MDS-UPDRS)
The MDS-UPDRS is defined by 4 Parts, each composed by a different number of items. The MDS-UPDRS has a minimum score of 0 and a maximum score of 260. The higher the score, the more severe the impairment.
Time frame: 12 months
multiple system atrophy: Unified Multiple System Atrophy Rating Scale（Part I and Part II）
UMSARS is a clinical tool designed to assess the severity and progression of MSA. The scale is divided into multiple parts, with Part I focusing on functional disability based on the history and self-report symptoms and Part II the severity of motor symptoms through a physical examination. The higher score, the severer impairment.
Time frame: 12 months
lewy body dementia: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
ADCS-CGIC provides a clinician-rated, subjective evaluation of a patient\'s cognitive, behavioral, and functional performance based on interviews and observations. The scoring typically uses a 7-point scale. The lower score, the better changes in overall condition.
Time frame: 12 months
frontotemporal dementia: CDR Dementia Staging Instrument PLUS National Alzheimer's Coordinating Center Behavior and Language Domains（CDR+NACC FTLD）
The CDR Dementia Staging Instrument provides a global assessment of cognitive and functional decline, while the NACC Behavior and Language Domains offer a more nuanced view of neuropsychiatric symptoms and language impairments.
Time frame: 12 months
Amyotrophic lateral sclerosis: Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability).
Time frame: 6 months
Barthel index
The Barthel Index is used for measuring a person\'s ability to perform basic activities of daily living.Scores typically range from 0 (totally dependent) to 100 (completely independent), with higher scores indicating greater independence in daily functioning.
Time frame: 6 months, 12months
mini mental status exam(MMSE)
The Mini-Mental State Examination (MMSE) is used for assessing cognitive function. The MMSE is scored out of a total of 30 points. A higher score indicates better cognitive function.
Time frame: 6 months, 12months
EQ-5D-5L
The EQ-5D-5L is used to measure health-related quality of life. The EQ-5D-5L assesses health on a scale of 0 to 25. A higher score means a lower quality of life.
Time frame: 6 months, 12months
Alzheimer's disease: sum of boxes of the CDR（CDR-SB）
The CDR-SB is used to assess the severity of cognitive impairment and dementia. The total score can range from 0 to 18, where higher scores indicate greater levels of impairment across the domains.
Time frame: 6 months, 12months
Alzheimer's disease: Alzheimer's Disease Cooperative Study - Activities of Daily Living （ADCS-ADL）
The ADCS-ADL is used to assess functional decline in patients with Alzheimer's disease, especially in the mild to moderate stages. The total score ranges from 0 to 78 , with higher scores indicating greater functional independence.
Time frame: 6 months, 12months
multiple system atrophy: Composite Autonomic Symptom Score
The COMPASS questionnaire is used to evaluate autonomic dysfunction, which can present with a variety of symptoms.Higher scores indicate greater impairment in autonomic function.
Time frame: 6 months, 12months
Clinical Global Impression
CGI is used to assess the severity of a patient's illness, the change in their condition over time, and the efficacy of treatments. It is scored on a 7-point scale, with a higher score indicating a worsen condition.
Time frame: 6 months, 12months
lewy body dementia: MDS-UPRDS
Time frame: 6 months, 12months
Lewy body dementia：Neuropsychiatric Inventory（NPI）
NPI is used to assess neuropsychiatric symptoms and behavioral disturbances in individuals. The Total NPI Score ranges from 0 to 144. Higher scores indicate greater overall severity of neuropsychiatric disturbances.
Time frame: 6 months, 12months
frontotemporal dementia: NPI
Time frame: 6 months, 12months
frontotemporal dementia: ADAS-cog
Time frame: 6 months, 12months
Amyotrophic lateral sclerosis: Change in forced vital capacity to predicted value ratio (FVC% pred)
Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration.
Time frame: 6 months
Amyotrophic lateral sclerosis: Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40).
ALSAQ-40 score ranges from 0 to 160 points, and higher scores indicate better quality of life.
Time frame: 6 months
Amyotrophic lateral sclerosis: Change in the Edinburgh Cognitive and Behavioral ALS Screen (ECAS).
ECAS determine cognitive and behavioral changes of patients suffering from Amyotrophic Lateral Sclerosis. With ECAS, ALS-specific (fluency, executive functions and social cognition, language; minimum score = 0, maximum score = 100) and ALS-nonspecific (memory, visuospatial functions; minimum score = 0, maximum score = 36) functions can be analyzed to enable the distinction from other diseases with cognitive and behavioral impairments.
Time frame: 6 months
Amyotrophic lateral sclerosis: Change in the Neurophysiological Index (NI) and Compound Muscle Action Potential (CMAP) score.
The NI is derived from the CMAP, the DML and the F-wave frequency (CMAP amplitude/DML) x F frequency %), representing aspects of the effects of denervation and reinnervation, of degeneration of the terminal part of the motor axons, and of the excitability of anterior horn cells. The negative amplitudes of the CMAP for motor nerve conduction in the median and ulnar nerves in the upper extremities as well as the peroneal and tibial nerves in the lower extremities of ALS patients were recorded (median nerve-wrist, ulnar-wrist, peroneal-ankle, tibial-ankle). These nerves were scored based on the decrease in the amplitudes of each nerve CMAP- 0 (CMAP\> =\[X-2s\]), 1 (50% \[X-2s\] \< CMAP \< \[X-2s\]), 2 (30% \[X-2s\] \< CMAP \< 50% \[X-2s\]), 3 (CMAP \< =30% \[X-2s\]), respectively. The values of X and S for different nerves and different patient age groups, which were applied in the electrophysiology examination room.
Time frame: 6 months
Amyotrophic lateral sclersis: Change in the Rasch Overall ALS Disability Scale (ROADS).
ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.
Time frame: 6 months
Adverse effects
Time frame: 3months, 6 months, 12months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Aug 2027, 25 months later.
Of 73 non-industry phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's planned 25 months is below that.
Counting every sponsor, half of 234 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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