Acute Ischemic StrokePhase 2ASSISTNCT06759753
Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
A Phase 2 study testing Aleeto in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Aleeto
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2025to 31 Jan 2026
- Phase
- Phase 2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years (30 ≤ age ≤ 80).
- Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019."
- Time from symptom onset ≤ 72 hours.
- NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS.
- Pre-stroke mRS (modified Rankin Scale) < 2, indicating independent activities of daily living.
- Signed informed consent.
Who cannot join
- Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.
- Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.).
- History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HBV DNA positive or serum HBV DNA > 2 × 10^8 IU/ml).
- Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value>3 times normal upper limit or Aspartate aminotransferase (AST)>3 times normal upper limit; Severe renal insufficiency is defined as creatinine>1.5 times normal upper limit or creatinine clearance < 50 ml/min, or over stage 3 of chronic kidney disease), severe heart failure (New York Heart Association grades III - IV).
- Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg.
- History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia, drug-induced hematology or liver dysfunction, white blood cell count <2×10^9/L or platelet count <100×10^9/L.
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- History of severe anemia within the past 1 month (hemoglobin < 90g/L).
- Body Mass Index (BMI) < 16kg/m2 or BMI> 35kg/m2.
- Severe organic diseases with expected survival time <5 years, such as malignant tumor.
- Women of child bearing potential, pregnant or breastfeeding.
- Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation.
- Combined with alcohol and drug abuse history.
- Known history of allergy to biological agents such as proteins and cell products.
- History of intracranial or spinal surgery, major surgery, or severe physical trauma within the past 4 weeks.
- Received any vaccinations within the past 28 days.
- Use of other investigational drugs within 30 days or 5 drug half-lives.
- Unable to complete follow-up due to geographical or other reasons.
- The researchers believe that the patient is not suitable to participate in this study.
- Participated in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
WeiQi Chen contact
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing
Yilong Wang, 59975885, yilong528@gmail.com
About this study
This study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. It also aims to explore the neuroprotective effects of Aleeto in moderate to severe acute ischemic stroke and provide data support and evidence for future clinical trials and evidence-based medicine.
Read the detailed description
Stroke is the second leading cause of death worldwide, associated with high rates of morbidity, mortality, and disability. As a result, it places a significant social and economic burden on societies. Stroke is generally classified into two types: ischemic stroke and hemorrhagic stroke. Acute ischemic stroke (AIS) accounts for approximately 87% of all stroke cases, characterized by the sudden cessation of oxygen and blood supply to local cerebral tissue due to arterial occlusion.
According to the Global Burden of Disease study, in 2019, there were 28.76 million stroke patients in China, including 3.94 million new cases and 2.19 million deaths due to stroke. The burden of ischemic stroke (IS) in China has increased dramatically, with the Disability-Adjusted Life Years (DALYs) for IS rising by 138.6% from 1990 to 2019. This burden is expected to grow further due to the aging population, the persistently high incidence of stroke risk factors (such as hypertension), and inadequate management. Although significant advances have been made in the diagnosis and treatment of ischemic stroke in recent years-resulting in a notable reduction in recurrence rates-effective, targeted treatments to reduce disability and improve neurological recovery remain limited.
Aleeto, derived from cellular exosomes, is a group of specific protein polymers secreted by stem cells under stress. These exosomes possess several advantages, including selective assembly, targeted delivery, efficient tissue repair, high safety, stable chemical properties, and ease of preservation. Moreover, Aleeto has demonstrated strong potential for nerve repair.
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of Aleeto in patients with acute ischemic stroke. The trial also aims to determine the appropriate dosage for future clinical studies.
A total of 192 patients will be enrolled and randomly assigned to three groups. All participants will receive standardized treatment according to clinical guidelines, along with ginkgo ester dropping pills (4 pills per dose, 3 times per day, for 90 days of oral treatment). The dosage and type of drugs used will remain consistent throughout the trial.
Experimental Group 1: Intravenous administration of Aleeto at 130 μg/day for 14 ± 2 days (130 μg Aleeto dissolved in 100 mL sodium chloride injection).
Experimental Group 2: Intravenous administration of Aleeto at 260 μg/day for 14 ± 2 days (260 μg Aleeto dissolved in 100 mL sodium chloride injection).
Placebo Group: A placebo with the same appearance, odor, and color as Aleeto will be administered in the same manner and for the same duration as the experimental groups.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Aleeto, Placebo
- Keywords
- Aleeto, Placebo parallel-controlled, Double Blind Study, Randomized Controlled Trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AleetoDrug
According to the groups, patients would be treated with Aleeto via intravenous injection, and the specific dosage of Aleeto will depend on the grouping.
PlaceboDrug
Placebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Intravenous administration of Aleeto at 130μg/day for 14±2 days (130μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. Receives: Drug: Aleeto |
| Experimental group 2 | Experimental | Intravenous administration of Aleeto at 130μg/day for 14±2 days (260μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. Receives: Drug: Aleeto |
| Placebo group | Placebo comparator | Placebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment, along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in NIH Stroke Scale
NIH Stroke Scale (NIHSS) scores from 0 to 42. A higher score indicates worse neural function.
Measured: At 14 days after randomization
Secondary outcomes (10)
Change from baseline in NIH Stroke Scale
NIH Stroke Scale (NIHSS) scores from 0 to 42. A higher score indicates worse neural function.
Measured: At 7±1 days after randomization.
Change from baseline in Modified Rankin Scale
Modified Rankin Scale (mRS) ranks from 0 to 5. A higher rank indicates worse neural function.
Measured: At 90±7days after randomization
Change from baseline in Fugl-Meyer Assessment
Fugl-Meyer Assessment (FMA) socres from 0 to 226. A higher score indicates better motor function.
Measured: At 14±2 and 90±7days after randomization.
Change from baseline in Ashworth scale
Ashworth scale ranks from 0 to 5. A higher rank indicates worse motor function.
Measured: At 14±2 and 90±7days after randomization.
The ratio of modified Barthel index ≥95 points
Modified Barthel index socres from 0 to 100. A higher score indicates better self-care ability.
Measured: At 90±7days after randomization.
Change from baseline in Visual Analogue Scale
Visual Analogue Scale (VAS) ranks from 0 to 10. A higher rank indicates higher pain level.
Measured: At 14±2 and 90±7days after randomization.
Change from baseline in Montreal Cognitive Assessment
Montreal Cognitive Assessment (MoCA) socres from 0 to 30. A higher score indicates better cognitive function.
Measured: At 90±7days after randomization.
Combined vascular events
Including stroke (including ischemic and hemorrhagic stroke), myocardial infarction and cardiovascular death
Measured: From randomization to the end of treatment at 90±7days
New-onset Stroke Events
Including hemorrhagic and ischemic strokes
Measured: From randomization to the end of treatment at 90±7days
All-cause Mortality
Measured: From randomization to the end of treatment at 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start21 Mar 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a prospective, double-blind, 1:1:1 randomized controlled study. 192 patients will be randomly assigned to 3 groups. Two dose groups are set 130μg/day and 260μg/day and one placebo group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 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
- Investigators
- YiLong Wang, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759753
- Sponsor's protocol ID
- HX-A-2024088
- Acronym
- ASSIST
- Status last verified
- Sep 2025
- First submitted
- 29 Dec 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06759753
- Acronym / sponsor ID
- ASSIST / HX-A-2024088
- Conditions
- Acute Ischemic Stroke
- Keywords
- Aleeto, Placebo parallel-controlled, Double Blind Study, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 6 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 study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. It also aims to explore the neuroprotective effects of Aleeto in moderate to severe acute ischemic stroke and provide data support and evidence for future clinical trials and evidence-based medicine.
Detailed description
Stroke is the second leading cause of death worldwide, associated with high rates of morbidity, mortality, and disability. As a result, it places a significant social and economic burden on societies. Stroke is generally classified into two types: ischemic stroke and hemorrhagic stroke. Acute ischemic stroke (AIS) accounts for approximately 87% of all stroke cases, characterized by the sudden cessation of oxygen and blood supply to local cerebral tissue due to arterial occlusion.
According to the Global Burden of Disease study, in 2019, there were 28.76 million stroke patients in China, including 3.94 million new cases and 2.19 million deaths due to stroke. The burden of ischemic stroke (IS) in China has increased dramatically, with the Disability-Adjusted Life Years (DALYs) for IS rising by 138.6% from 1990 to 2019. This burden is expected to grow further due to the aging population, the persistently high incidence of stroke risk factors (such as hypertension), and inadequate management. Although significant advances have been made in the diagnosis and treatment of ischemic stroke in recent years-resulting in a notable reduction in recurrence rates-effective, targeted treatments to reduce disability and improve neurological recovery remain limited.
Aleeto, derived from cellular exosomes, is a group of specific protein polymers secreted by stem cells under stress. These exosomes possess several advantages, including selective assembly, targeted delivery, efficient tissue repair, high safety, stable chemical properties, and ease of preservation. Moreover, Aleeto has demonstrated strong potential for nerve repair.
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of Aleeto in patients with acute ischemic stroke. The trial also aims to determine the appropriate dosage for future clinical studies.
A total of 192 patients will be enrolled and randomly assigned to three groups. All participants will receive standardized treatment according to clinical guidelines, along with ginkgo ester dropping pills (4 pills per dose, 3 times per day, for 90 days of oral treatment). The dosage and type of drugs used will remain consistent throughout the trial.
Experimental Group 1: Intravenous administration of Aleeto at 130 μg/day for 14 ± 2 days (130 μg Aleeto dissolved in 100 mL sodium chloride injection).
Experimental Group 2: Intravenous administration of Aleeto at 260 μg/day for 14 ± 2 days (260 μg Aleeto dissolved in 100 mL sodium chloride injection).
Placebo Group: A placebo with the same appearance, odor, and color as Aleeto will be administered in the same manner and for the same duration as the experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This trial is a prospective, double-blind, 1:1:1 randomized controlled study. 192 patients will be randomly assigned to 3 groups. Two dose groups are set 130μg/day and 260μg/day and one placebo group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: AleetoIntravenous administration of Aleeto at 130μg/day for 14±2 days (130μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. |
| Experimental group 2 | Experimental | Drug: AleetoIntravenous administration of Aleeto at 130μg/day for 14±2 days (260μg Aleeto with 100 ml sodium chloride injection), along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment, along with Ginkgo Ester Dropping Pills, 4 pills per dose, 3 times/day, orally, for 90 days. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 30 and 80 years (30 ≤ age ≤ 80).
- Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019."
- Time from symptom onset ≤ 72 hours.
- NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS.
- Pre-stroke mRS (modified Rankin Scale) < 2, indicating independent activities of daily living.
Key exclusion criteria (19 listed)
- Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.
- Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.).
- History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HBV DNA positive or serum HBV DNA > 2 × 10^8 IU/ml).
- Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value>3 times normal upper limit or Aspartate aminotransferase (AST)>3 times normal upper limit; Severe renal insufficiency is defined as creatinine>1.5 times normal upper limit or creatinine clearance < 50 ml/min, or over stage 3 of chronic kidney disease), severe heart failure (New York Heart Association grades III - IV).
- Resistant Hypertension, systolic pressure ≥220mmHg or diastolic pressure ≥120mmHg.
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 |
|---|---|---|
| AleetoAccording to the groups, patients would be treated with Aleeto via intravenous injection, and the specific dosage of Aleeto will depend on the grouping. | Drug | Experimental group 1, Experimental group 2 |
| PlaceboPlacebo with the same dosage form, odor and color as Aleeto was administered in the same way and course of treatment. | Drug | Placebo group |
Primary outcome
Change from baseline in NIH Stroke Scale
Time frame: At 14 days after randomization
NIH Stroke Scale (NIHSS) scores from 0 to 42. A higher score indicates worse neural function.
10 secondary outcomes
Change from baseline in NIH Stroke Scale
Time frame: At 7±1 days after randomization.
Change from baseline in Modified Rankin Scale
Time frame: At 90±7days after randomization
Change from baseline in Fugl-Meyer Assessment
Time frame: At 14±2 and 90±7days after randomization.
Change from baseline in Ashworth scale
Time frame: At 14±2 and 90±7days after randomization.
The ratio of modified Barthel index ≥95 points
Time frame: At 90±7days after randomization.
Change from baseline in Visual Analogue Scale
Time frame: At 14±2 and 90±7days after randomization.
Change from baseline in Montreal Cognitive Assessment
Time frame: At 90±7days after randomization.
Combined vascular events
Time frame: From randomization to the end of treatment at 90±7days
New-onset Stroke Events
Time frame: From randomization to the end of treatment at 90±7days
All-cause Mortality
Time frame: From randomization to the end of treatment at 90±7 days
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 3 Sep 2025.
- 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.
WeiQi Chen contact
YiLong Wang principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aleeto in people with Acute 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 6 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 3 Sep 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 YiLong Wang (59975885, yilong528@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in NIH Stroke Scale (time frame: At 14 days after randomization). 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 Sep 2025.