Acute Ischemic StrokePhase 1NCT07628933
A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke
A Phase 1 study testing Human Umbilical Cord Mesenchymal Stem Cells Injection in people with Acute Ischemic Stroke and AIS, run by BOE Technology Group Co., Ltd. at 1 site in China.
Trial summary
Study Methods: The trial consists of two phases, both including a placebo control. Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, AIS
- What is being tested?
- Human Umbilical Cord Mesenchymal Stem Cells Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Nov 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, both genders included.
- Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms.
- National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of <2 on item Ia of the NIHSS.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
- The participant voluntarily agrees to participate in this study, signs the informed consent form personally or via a legal guardian, and has good compliance.
Who cannot join
- Planned or already performed thrombectomy for the current stroke.
- Treatment with neuroprotective agents after the current stroke.
- History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial.
- Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin >8.5%, or poorly controlled blood glucose [blood glucose >16.8 mmol/L or <2.8 mmol/L]), renal disease (eGFR <30 mL/min), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association [NYHA] Class IV), severe chronic respiratory disease.
- Organ function meeting any one or more of the following criteria:
- Absolute neutrophil count (ANC) <1.5×10⁹/L, platelet count (PLT) <100×10⁹/L, hemoglobin (Hb) <90 g/L;
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- Aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >2.5×ULN, serum total bilirubin (TBIL) >1.5×ULN;
- Creatinine (Cr) >1.5×ULN;
- For patients not receiving anticoagulant or antithrombotic therapy: international normalized ratio (INR) >1.7 or activated partial thromboplastin time (APTT) >1.25×ULN; for patients receiving anticoagulant or antithrombotic therapy: INR >3.0 or APTT >1.5×ULN.
- Diagnosis of immunodeficiency disease, or long-term use of immunosuppressants or systemic corticosteroids at high doses within a short period before screening.
- Epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological or psychiatric disorders that, in the investigator's opinion, could affect the participant's ability to participate in the trial or interfere with study assessments.
- Presence of autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
- Inability to undergo cranial CT/MRI examination for any reason (e.g., metallic implants such as cardiac pacemakers, claustrophobia, etc.).
- Participation in another clinical trial of an investigational drug within 3 months before screening.
- Pregnancy, breastfeeding, planned pregnancy, or inability to use effective contraceptive measures.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this study.
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
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Shu ya Li Chief Physician, +86 13601367028, shuyali85@163.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord-derived Mesenchymal Stromal Cell Injection in Patients With Acute Ischemic Stroke (AIS)
Study Methods: The trial consists of two phases, both including a placebo control.
Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group.
Phase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.
Read the detailed description
Objective of this study: To preliminarily evaluate the safety and efficacy of human umbilical cord-derived mesenchymal stromal cell injection in the treatment of AIS.
Study methods: This trial is divided into two phases, both including a placebo control.
Phase I (Ia): A multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Three dose groups are set: low dose (5.0×10⁷ cells), medium dose (1.0×10⁸ cells), and high dose (2.0×10⁸ cells). The low-dose group enrolls 3-6 participants (all receiving the investigational product, with the first of the first 3 participants as a sentinel). The medium- and high-dose groups each enroll 8 participants (2 sentinels receiving the investigational product, and the remaining 6 randomized in a 2:1 ratio to the investigational product or placebo group). Phase Ia plans to enroll 19-22 participants. Dose escalation to the next dose group is permitted only after all participants in the previous dose group have completed dosing and been observed for at least 28 days with a favorable safety assessment.
Phase Ib: A multicenter, randomized, double-blind, placebo-controlled, dose-escalation, multiple-dose trial. Based on the results of Phase Ia, two dose groups will be selected. The initial plan is to administer the product on Day 0, Day 7, and Day 14 (3 doses in total). Each dose group enrolls 8 participants (6 receiving the investigational product, 2 receiving placebo), for a total of 16 participants. Escalation to the next higher dose group is permitted only after all participants in the previous dose group have completed the three doses and been observed for at least 28 days with a favorable safety assessment.
Study duration: 720 days
- Conditions
- Acute Ischemic Stroke, AIS
- Being tested
- Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection, Human Umbilical Cord Mesenchymal Stem Cells Injection
- Keywords
- AIS, hUC-MSCs
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo of Human Umbilical Cord Mesenchymal Stromal Cells InjectionDrug
Placebo refers to a cell-free product, whose packaging, storage conditions, expiration date, and method of administration remain consistent with those of the investigational drug.
Human Umbilical Cord Mesenchymal Stem Cells InjectionDrug
the first phase (Phase Ia) is a single-dose administration
Human Umbilical Cord Mesenchymal Stem Cells InjectionDrug
the second phase (Phase Ib) is a multiple-dose administration.
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group） | Experimental | 5.0×10^7 cells,Single intravenous infusion Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） | Experimental | 1.0×10^8 cells,Single intravenous infusion Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group） | Experimental | 2.0×10^8 cells,Single intravenous infusion Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） | Placebo comparator | 1.0×10^8 cells,Single intravenous infusion Receives: Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group） | Placebo comparator | 2.0×10^8 cells,Single intravenous infusion Receives: Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection 1 | Experimental | Based on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection 2 | Experimental | Based on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1 | Placebo comparator | Based on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. Receives: Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2 | Placebo comparator | Based on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. Receives: Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT (Dose-Limiting Toxicity) events;
Measured: Day28
All adverse events/serious adverse events during the trial;
Measured: 2year
All-cause mortality
Measured: Day90、Day180、Day360
Secondary outcomes (6)
Proportion of participants with an Modified Rankin Scale (mRS) score of 0-2
The modified Rankin Scale (mRS) is a widely used clinical outcome measure that assesses the degree of disability or dependence in the daily activities of patients who have suffered a stroke or other neurological conditions. It is a simple, 7-level ordinal scale ranging from 0 to 6:
0 - No symptoms at all.
- - No significant disability: able to perform all usual activities despite some symptoms.
- - Slight disability: unable to carry out all previous activities but able to look after own affairs without assistance.
- - Moderate disability: requires some help but able to walk without assistance.
- - Moderately severe disability: unable to walk or attend to bodily needs without assistance.
- - Severe disability: bedridden, incontinent, requiring constant nursing care.
- - Dead.
A higher score indicates more severe disability. The mRS is the most common primary endpoint in acute stroke clinical trials, with a score of 0-2 at 90 days often defined as a "good outcome.
Measured: Day 30, Day90, Day180, Day360
Proportion of participants with a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score from baseline
The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively quantify the severity of neurological deficits in patients with stroke. It consists of 15 items, including assessments of consciousness, eye movements, visual fields, facial palsy, motor and sensory function, language, speech, and neglect. Each item is scored, with a total score ranging from 0 to 42. Higher scores indicate more severe neurological impairment. The NIHSS is widely used in clinical practice and research to evaluate stroke severity, guide treatment decisions, and predict patient outcomes.
Measured: Day 7, Day 14, Day 30, Day 90, Day 180, Day 360
Change from baseline in National Institutes of Health Stroke Scale(NIHSS) score
Measured: Day 7, Day 14, Day 30, Day 90, Day 180, Day 360
Proportion of participants with a Barthel Index ≥95
The Barthel Index (BI) is a standardized ordinal scale used to measure a person's performance in activities of daily living (ADL). It assesses 10 basic functions, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (e.g., bed to chair), mobility, and stair climbing. Each item is scored based on the amount of physical assistance required, with total scores typically ranging from 0 to 100 (or 0-20 in some versions). It is widely used in geriatrics, rehabilitation, and stroke research to evaluate functional independence and track changes over time.A higher Barthel Index score indicates greater functional independence (less need for assistance), while a lower score reflects greater disability and dependency. For example, a score of 100 means the patient is fully independent in basic ADL.
Measured: Day 30, Day 90, Day180, Day360
Change from baseline in the Fugl-Meyer Motor Function Assessment Scale score
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index widely recognized as a gold standard scale for evaluating sensorimotor recovery in patients with post-stroke hemiplegia. A higher FMA score indicates better motor function and less impairment, reflecting more positive outcomes in stroke recovery. For example, the motor domain score ranges from 0 (complete hemiplegia) to 100 (normal motor performance). The total FMA score is therefore a direct measure of functional recovery: the higher the score, the greater the improvement in sensorimotor function following stroke.
Measured: Day 30, Day90, Day180, Day 360
Change from baseline in objective imaging findings （CT/MRI)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Nov 2029 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BOE Technology Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628933
- Sponsor's protocol ID
- YW2026-016-02
- Status last verified
- Jun 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord-derived Mesenchymal Stromal Cell Injection in Patients With Acute Ischemic Stroke (AIS)
- ClinicalTrials.gov ID
- NCT07628933
- Acronym / sponsor ID
- YW2026-016-02
- Conditions
- Acute Ischemic Stroke, AIS
- Keywords
- AIS, hUC-MSCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- BOE Technology Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 5 Jun 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.
Study Methods: The trial consists of two phases, both including a placebo control.
Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group.
Phase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.
Detailed description
Objective of this study: To preliminarily evaluate the safety and efficacy of human umbilical cord-derived mesenchymal stromal cell injection in the treatment of AIS.
Study methods: This trial is divided into two phases, both including a placebo control.
Phase I (Ia): A multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Three dose groups are set: low dose (5.0×10⁷ cells), medium dose (1.0×10⁸ cells), and high dose (2.0×10⁸ cells). The low-dose group enrolls 3-6 participants (all receiving the investigational product, with the first of the first 3 participants as a sentinel). The medium- and high-dose groups each enroll 8 participants (2 sentinels receiving the investigational product, and the remaining 6 randomized in a 2:1 ratio to the investigational product or placebo group). Phase Ia plans to enroll 19-22 participants. Dose escalation to the next dose group is permitted only after all participants in the previous dose group have completed dosing and been observed for at least 28 days with a favorable safety assessment.
Phase Ib: A multicenter, randomized, double-blind, placebo-controlled, dose-escalation, multiple-dose trial. Based on the results of Phase Ia, two dose groups will be selected. The initial plan is to administer the product on Day 0, Day 7, and Day 14 (3 doses in total). Each dose group enrolls 8 participants (6 receiving the investigational product, 2 receiving placebo), for a total of 16 participants. Escalation to the next higher dose group is permitted only after all participants in the previous dose group have completed the three doses and been observed for at least 28 days with a favorable safety assessment.
Study duration: 720 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group） | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection5.0×10^7 cells,Single intravenous infusion |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection1.0×10^8 cells,Single intravenous infusion |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group） | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection2.0×10^8 cells,Single intravenous infusion |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） | Placebo comparator | Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection1.0×10^8 cells,Single intravenous infusion |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group） | Placebo comparator | Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection2.0×10^8 cells,Single intravenous infusion |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection 1 | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cells InjectionBased on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. |
| Human Umbilical Cord Mesenchymal Stromal Cells Injection 2 | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cells InjectionBased on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1 | Placebo comparator | Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells InjectionBased on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. |
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2 | Placebo comparator | Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells InjectionBased on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years, both genders included.
- Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms.
- National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of <2 on item Ia of the NIHSS.
- Pre-stroke modified Rankin Scale (mRS) score ≤1.
- The participant voluntarily agrees to participate in this study, signs the informed consent form personally or via a legal guardian, and has good compliance.
Key exclusion criteria (16 listed)
- Planned or already performed thrombectomy for the current stroke.
- Treatment with neuroprotective agents after the current stroke.
- History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial.
- Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin >8.5%, or poorly controlled blood glucose [blood glucose >16.8 mmol/L or <2.8 mmol/L]), renal disease (eGFR <30 mL/min), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association [NYHA] Class IV), severe chronic respiratory disease.
- Organ function meeting any one or more of the following criteria:
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 |
|---|---|---|
| Placebo of Human Umbilical Cord Mesenchymal Stromal Cells InjectionPlacebo refers to a cell-free product, whose packaging, storage conditions, expiration date, and method of administration remain consistent with those of the investigational drug. | Drug | Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1, Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2, Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）, Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） |
| Human Umbilical Cord Mesenchymal Stem Cells Injectionthe first phase (Phase Ia) is a single-dose administration | Drug | Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）, Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group）, Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group） |
| Human Umbilical Cord Mesenchymal Stem Cells Injectionthe second phase (Phase Ib) is a multiple-dose administration. | Drug | Human Umbilical Cord Mesenchymal Stromal Cells Injection 1, Human Umbilical Cord Mesenchymal Stromal Cells Injection 2 |
Primary outcome
Incidence of DLT (Dose-Limiting Toxicity) events;
Time frame: Day28
All adverse events/serious adverse events during the trial;
Time frame: 2year
All-cause mortality
Time frame: Day90、Day180、Day360
6 secondary outcomes
Proportion of participants with an Modified Rankin Scale (mRS) score of 0-2
Time frame: Day 30, Day90, Day180, Day360
Proportion of participants with a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score from baseline
Time frame: Day 7, Day 14, Day 30, Day 90, Day 180, Day 360
Change from baseline in National Institutes of Health Stroke Scale(NIHSS) score
Time frame: Day 7, Day 14, Day 30, Day 90, Day 180, Day 360
Proportion of participants with a Barthel Index ≥95
Time frame: Day 30, Day 90, Day180, Day360
Change from baseline in the Fugl-Meyer Motor Function Assessment Scale score
Time frame: Day 30, Day90, Day180, Day 360
Change from baseline in objective imaging findings （CT/MRI)
Time frame: Day 90
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 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human Umbilical Cord Mesenchymal Stem Cells Injection in people with Acute Ischemic Stroke and AIS, run by BOE Technology 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 16 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 5 Jun 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 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 Yongjun Wang Chief Physician, Professor (010-59978538, yongjunwang111@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (Dose-Limiting Toxicity) events; (time frame: Day28). The study lists 3 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 5 Jun 2026.