Acute Ischemic StrokePhase 1/2NCT07371624
A Study of B2065 in Patients With Acute Ischemic Stroke
A Phase 1/2 study testing B2065 in people with Acute Ischemic Stroke, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- B2065
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to Dec 2027
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.
- Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).
- Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).
- NIHSS score at screening is 8 to 20.
- The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.
Who cannot join
- Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.
- Modified Rankin Scale (mRS) score ≥2 before stroke onset.
- Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.
- Patients who are unable to undergo CT and/or MRI examinations.
- Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
- Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.
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- Body temperature >38°C prior to dosing, and the investigator assesses that there is a risk of infection.
- Patients with uncontrollable active infection; or patients who have received systemic anti-infective therapy within 7 days prior to dosing and, in the investigator's judgment, may be likely to convert to uncontrollable active infection in the short term.
- Patients with current or prior severe diseases of other organ systems, including but not limited to:
- Patients with severe heart failure (NYHA Class III or IV) and/or severe respiratory failure;
- Patients with renal disease with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²;
- Advanced liver disease, such as hepatitis or liver cirrhosis;
- Patients positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); patients positive for hepatitis B e antibody (HBeAb) and/or hepatitis B core antibody (HBcAb) with quantitative HBV-DNA above the upper limit of normal; patients with any of the following test results positive: hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab);
- Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and/or diastolic blood pressure ≥110 mmHg;
- Blood glucose <2.8 mmol/L (50 mg/dL) or >22.2 mmol/L (400 mg/dL).
- Screening laboratory tests meeting any of the following criteria:
- Serum alanine aminotransferase (ALT) ≥3× upper limit of normal (ULN);
- Serum aspartate aminotransferase (AST) ≥3× ULN;
- Serum creatinine (Cr) ≥2× ULN;
- Absolute neutrophil count (ANC) <1.5×10^9/L;
- Platelet count (PLT) <100×10^9/L;
- Hemoglobin (Hgb) <90 g/L;
- International normalized ratio (INR) >1.7 or activated partial thromboplastin time (APTT) >1.25× ULN.
- Patients with malignant tumors or other diseases with an expected survival of less than 2 years.
- Patients with other acquired or congenital immunodeficiency diseases, or those currently using immunosuppressants.
- Patients who, upon screening inquiry, have alcohol dependence or a history of drug abuse.
- Pregnant or breastfeeding women; or those who plan to conceive, donate sperm, or donate oocytes during the trial and/or are unwilling to take effective contraception measures.
- Patients who participated in any other clinical trial within 1 month prior to screening.
- Patients who are allergic to any component of the investigational product.
- Patients deemed by the investigator to be unsuitable 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, Capital Medical University
Beijing
YongJun WANG, 86 010-59975527, yongjunw@hotmail.com
About this study
Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Adipose-Derived Mesenchymal Stromal Cell Injection (B2065) in Participants With Acute Ischemic Stroke.
The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. The main questions it aims to answer are:
At what dose range is the drug safe for participants?
Which dose shows preliminary efficacy?
Researchers will compare B2065 to a placebo (a look-alike substance that contains no drug) to see if B2065 works to treat acute ischemic stroke.
Participants will:
Receive a single dose of B2065 during hospitalization
Visit the hospital as scheduled for safety and efficacy assessments
- Conditions
- Acute Ischemic Stroke
- Being tested
- B2065, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B2065Drug
Administered by intravenous infusion.
PlaceboDrug
Administered by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| B2065 | Experimental | Phase I dose escalation includes 5.0×10^7 cells (1 bag), 1.5×10^8 cells (3 bags), and 4.5×10^8 cells (9 bags), formulated in 1% human serum albumin and sodium chloride injection.
Phase IIa dose expansion will select 1-2 dose cohorts from Phase I. Participants will be randomized in a 2:1 ratio (B2065:placebo). Receives: Drug: B2065 |
| Placebo | Placebo comparator | Placebo (1% human serum albumin in sodium chloride injection) administered by intravenous infusion, with matched volume and number of bags. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) [Safety]
Percentage of participants experiencing DLTs during the Phase 1 dose-escalation stage.
Measured: Within 28 days after dosing.
Incidence of Infusion-Related Reactions [Safety]
Percentage of participants experiencing infusion-related reactions, including hypersensitivity reactions and systemic complications.
Measured: Within 7 days, 14 days, and 28 days.
All-Cause Mortality Rate [Safety]
Proportion of participants who die from any cause during the study period.
Measured: Within 14 days,12 months, and 24 months.
Incidence of abnormal imaging findings indicative of tumorigenicity [Safety]
Percentage of participants with newly detected tumorous lesions as assessed by chest and abdominal CT scans.
Measured: Month 6 and month 24.
Change from baseline in serum tumor marker levels [Safety]
Evaluation of serum levels of tumor markers
Measured: Change from baseline at Month 6 and Month 24.
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Safety]
Percentage of participants experiencing one or more TEAEs, serious adverse events (SAEs), or adverse events leading to study discontinuation.
Measured: Day1 to month 24 post-dose.
Secondary outcomes (6)
Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-2 [Efficacy]
Percentage of participants achieving functional independence (mRS score 0-2). The mRS is a 7-level scale ranging from 0 (no symptoms) to 6 (death).
Measured: Day 28, day 90, month 6, and month 12.
Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 [Efficacy]
Percentage of participants achieving a favorable clinical outcome (mRS score 0-1).
Measured: Day 28, day 90, month 6, and month 12.
Proportion of participants with neurological improvement based on NIH Stroke Scale (NIHSS) [Efficacy]
Percentage of participants with a decrease in NIHSS score of ≥4 points from baseline, or achieving an absolute NIHSS score ≤1.
Measured: 24 hours, day 3, day 7, day 14, and month 12.
Change from baseline in NIH Stroke Scale (NIHSS) score [Efficacy]
Quantitative assessment of neurological deficit changes from baseline. Scores range from 0 (no deficit) to 42 (severe deficit).
Measured: 24 hours, day 3, day 7, day 14, and month 12.
Proportion of participants achieving a Barthel Index (BI) score of 95-100 [Efficacy]
Percentage of participants with slight or no disability (BI score 95-100). Total score ranges from 0 (complete dependence) to 100 (independence).
Measured: Day 28, day 90, month 6, and month 12.
Change from baseline in EQ-5D-5L Index Score [Quality of Life]
Standardized measure of health status across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Measured: Day 28, day 90, month 6, and month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start31 Dec 2025
- Primary completionDec 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 Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371624
- Sponsor's protocol ID
- TSL-BM-B2065-I/IIa
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Allogeneic Adipose-Derived Mesenchymal Stromal Cell Injection (B2065) in Participants With Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT07371624
- Acronym / sponsor ID
- TSL-BM-B2065-I/IIa
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jan 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.
The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. The main questions it aims to answer are:
At what dose range is the drug safe for participants?
Which dose shows preliminary efficacy?
Researchers will compare B2065 to a placebo (a look-alike substance that contains no drug) to see if B2065 works to treat acute ischemic stroke.
Participants will:
Receive a single dose of B2065 during hospitalization
Visit the hospital as scheduled for safety and efficacy assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B2065 | Experimental | Drug: B2065Phase I dose escalation includes 5.0×10^7 cells (1 bag), 1.5×10^8 cells (3 bags), and 4.5×10^8 cells (9 bags), formulated in 1% human serum albumin and sodium chloride injection. Phase IIa dose expansion will select 1-2 dose cohorts from Phase I. Participants will be randomized in a 2:1 ratio (B2065:placebo). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (1% human serum albumin in sodium chloride injection) administered by intravenous infusion, with matched volume and number of bags. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.
- Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).
- Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).
- NIHSS score at screening is 8 to 20.
- The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.
Key exclusion criteria (30 listed)
- Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.
- Modified Rankin Scale (mRS) score ≥2 before stroke onset.
- Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.
- Patients who are unable to undergo CT and/or MRI examinations.
- Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
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 |
|---|---|---|
| B2065Administered by intravenous infusion. | Drug | B2065 |
| PlaceboAdministered by intravenous infusion. | Drug | Placebo |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) [Safety]
Time frame: Within 28 days after dosing.
Percentage of participants experiencing DLTs during the Phase 1 dose-escalation stage.
Incidence of Infusion-Related Reactions [Safety]
Time frame: Within 7 days, 14 days, and 28 days.
Percentage of participants experiencing infusion-related reactions, including hypersensitivity reactions and systemic complications.
All-Cause Mortality Rate [Safety]
Time frame: Within 14 days,12 months, and 24 months.
Proportion of participants who die from any cause during the study period.
Incidence of abnormal imaging findings indicative of tumorigenicity [Safety]
Time frame: Month 6 and month 24.
Percentage of participants with newly detected tumorous lesions as assessed by chest and abdominal CT scans.
Change from baseline in serum tumor marker levels [Safety]
Time frame: Change from baseline at Month 6 and Month 24.
Evaluation of serum levels of tumor markers
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Safety]
Time frame: Day1 to month 24 post-dose.
Percentage of participants experiencing one or more TEAEs, serious adverse events (SAEs), or adverse events leading to study discontinuation.
6 secondary outcomes
Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-2 [Efficacy]
Time frame: Day 28, day 90, month 6, and month 12.
Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 [Efficacy]
Time frame: Day 28, day 90, month 6, and month 12.
Proportion of participants with neurological improvement based on NIH Stroke Scale (NIHSS) [Efficacy]
Time frame: 24 hours, day 3, day 7, day 14, and month 12.
Change from baseline in NIH Stroke Scale (NIHSS) score [Efficacy]
Time frame: 24 hours, day 3, day 7, day 14, and month 12.
Proportion of participants achieving a Barthel Index (BI) score of 95-100 [Efficacy]
Time frame: Day 28, day 90, month 6, and month 12.
Change from baseline in EQ-5D-5L Index Score [Quality of Life]
Time frame: Day 28, day 90, month 6, and month 12.
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 13 Aug 2026.
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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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing B2065 in people with Acute Ischemic Stroke, run by Tasly Pharmaceutical Group Co., Ltd 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 5 inclusion and 30 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 13 Aug 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. 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 combined 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) [Safety] (time frame: Within 28 days after dosing.). The study lists 6 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 13 Aug 2026.