Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)Phase 1/2NCT07896941
Safety and Efficacy of CG-BM1 in Ischemic Stroke
A Phase 1/2 study testing single infusion, 1.0 × 10^6 cells/kg, single infusion, 2.0 × 10^6 cells/kg and single infusion, 3.0 × 10^6 cells/kg in people with Ischemic Stroke or High-risk TIA (ABCD² ≥ 4), run by GuangZhou Cellgenes Biotechnology Co., Ltd. at 1 site in China.
Trial summary
1. To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Ischemic Stroke. 2. To observe the preliminary effectiveness of CG-BM1 in treating Ischemic Stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
- What is being tested?
- single infusion, 1.0 × 10^6 cells/kg, single infusion, 2.0 × 10^6 cells/kg and single infusion, 3.0 × 10^6 cells/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to 30 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years; male or female.
- 3 to 60 months after onset of ischemic stroke.
- Screening imaging shows ischemic stroke consistent with anterior circulation infarction, with no new infarct lesions.
- Currently receiving standard medical therapy for secondary prevention of stroke.
- Modified Rankin Scale (mRS) score 3-4.
- National Institutes of Health Stroke Scale (NIHSS) score 6-20, with item 1a <2.
- Willing to participate in the clinical trial; the participant or legal guardian signs the informed consent form and is willing to comply with all study procedures.
Who cannot join
- History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
- Previous stroke was of cardioembolic type.
- Presence of pressure ulcers at screening.
- History of epilepsy at any time or at screening, or current use of antiepileptic drugs.
- History or presence at screening of other neurological, psychiatric, joint, or muscle diseases that affect compliance or assessment.
- Malignancy within the past 5 years or at screening (except any cured malignancy with no evidence of tumor recurrence).
Show all 21Show fewer
- Pulmonary hypertension (World Health Organization [WHO] functional class III or IV) at screening.
- History of myocardial infarction within 6 months.
- 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 within 3 months, such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma, or HbA1c >8.5%); renal disease (eGFR <30 mL/min); hepatic failure (Child-Pugh class C); severe heart failure (New York Heart Association [NYHA] class IV); severe chronic respiratory disease.
- Deep vein thrombosis at screening or history of pulmonary embolism within 3 months before screening.
- Positive human immunodeficiency virus (HIV) test or diagnosis of syphilis at screening; immunodeficiency disease; or long-term or short-term high-dose immunosuppressant or systemic corticosteroid therapy before screening.
- Abnormal laboratory findings at screening as follows: hemoglobin <90 g/L, absolute neutrophil count <2.0×10^9/L, platelet count <100×10^9/L, absolute lymphocyte count <0.8×10^9/L.
- High risk of stroke recurrence as assessed by the investigator, or Essen Stroke Risk Score ≥5.
- Expected survival <12 months.
- Pregnant or breastfeeding; unwilling to use reliable contraception during the study (e.g., condoms); planning to donate sperm or oocytes; or planning to conceive.
- Participation in another interventional clinical trial within 3 months or 5 half-lives (for investigational drug interventions only, whichever is longer) before infusion.
- Participation in a stem cell clinical trial within 2 years.
- Known allergy to any known component of the study drug.
- History of drug abuse or alcoholism within the past year.
- Contraindications to MRI or inability to cooperate with MRI examination (e.g., cardiac pacemaker, claustrophobia).
- Any other factor that, in the investigator's judgment, makes the participant unsuitable for 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, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Zeng Jinsheng，Chief Physician, 020-87755766-8293, zjssumszsyy@163.com
About this study
Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Ischemic Stroke
- To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Ischemic Stroke.
- To observe the preliminary effectiveness of CG-BM1 in treating Ischemic Stroke patients.
- Being tested
- single infusion, 1.0 × 10^6 cells/kg, single infusion, 2.0 × 10^6 cells/kg, single infusion, 3.0 × 10^6 cells/kg, 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses, 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single infusion, 1.0 × 10^6 cells/kgBiological
CG-BM1
single infusion, 2.0 × 10^6 cells/kgBiological
CG-BM1
single infusion, 3.0 × 10^6 cells/kgBiological
CG-BM1
1.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesBiological
CG-BM1
2.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesBiological
CG-BM1
3.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesBiological
CG-BM1
Placebo, once every two weeks for a total of 3 doses.Biological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single administration-CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Administration procedure of CG-BM1: 1.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: single infusion, 1.0 × 10^6 cells/kg |
| Single administration-CG-BM1- 2.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 2.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: single infusion, 2.0 × 10^6 cells/kg |
| Single administration-CG-BM1- 3.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 3.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: single infusion, 3.0 × 10^6 cells/kg |
| Multiple administrations-CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Administration procedure of CG-BM1: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses |
| Multiple administrations-CG-BM1- 2.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses |
| Multiple administrations-CG-BM1- 3.0 × 10^6cells/kg | Experimental | Administration procedure of CG-BM1: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses |
| Placebo | Placebo comparator | Placebo is administered as an intravenous infusion once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. Receives: Biological: Placebo, once every two weeks for a total of 3 doses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Measured: Single administration: 21 days after dosing Multiple administration: 14 days after the last dose
Incidence of CG-BM1-related AEs and SAEs
Measured: 12 mouths after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Sep 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896941
- Sponsor's protocol ID
- CG-BM1-STROKE-01
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07896941
- Acronym / sponsor ID
- CG-BM1-STROKE-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 27 Oct 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.
- To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Ischemic Stroke.
- To observe the preliminary effectiveness of CG-BM1 in treating Ischemic Stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Single administration-CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Biological: single infusion, 1.0 × 10^6 cells/kgAdministration procedure of CG-BM1: 1.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Single administration-CG-BM1- 2.0 × 10^6cells/kg | Experimental | Biological: single infusion, 2.0 × 10^6 cells/kgAdministration procedure of CG-BM1: 2.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Single administration-CG-BM1- 3.0 × 10^6cells/kg | Experimental | Biological: single infusion, 3.0 × 10^6 cells/kgAdministration procedure of CG-BM1: 3.0 × 10^6 cells/kg as a single administration.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Multiple administrations-CG-BM1- 1.0 × 10^6 cells/kg | Experimental | Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesAdministration procedure of CG-BM1: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Multiple administrations-CG-BM1- 2.0 × 10^6cells/kg | Experimental | Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesAdministration procedure of CG-BM1: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Multiple administrations-CG-BM1- 3.0 × 10^6cells/kg | Experimental | Biological: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesAdministration procedure of CG-BM1: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
| Placebo | Placebo comparator | Biological: Placebo, once every two weeks for a total of 3 doses.Placebo is administered as an intravenous infusion once every two weeks for a total of 3 doses.Conventional treatment includes, but is not limited to: rehabilitation therapies, such as exercise therapy, speech therapy, cognitive therapy, electrical muscle stimulation, and swallowing therapy; antihypertensive, lipid-lowering, and anticoagulant therapies; management of complications and comorbidities; nutritional support; and other comprehensive treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years; male or female.
- 3 to 60 months after onset of ischemic stroke.
- Screening imaging shows ischemic stroke consistent with anterior circulation infarction, with no new infarct lesions.
- Currently receiving standard medical therapy for secondary prevention of stroke.
- Modified Rankin Scale (mRS) score 3-4.
Key exclusion criteria (21 listed)
- History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation.
- Previous stroke was of cardioembolic type.
- Presence of pressure ulcers at screening.
- History of epilepsy at any time or at screening, or current use of antiepileptic drugs.
- History or presence at screening of other neurological, psychiatric, joint, or muscle diseases that affect compliance or assessment.
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 |
|---|---|---|
| single infusion, 1.0 × 10^6 cells/kgCG-BM1 | Biological | Single administration-CG-BM1- 1.0 × 10^6 cells/kg |
| single infusion, 2.0 × 10^6 cells/kgCG-BM1 | Biological | Single administration-CG-BM1- 2.0 × 10^6cells/kg |
| single infusion, 3.0 × 10^6 cells/kgCG-BM1 | Biological | Single administration-CG-BM1- 3.0 × 10^6cells/kg |
| 1.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesCG-BM1 | Biological | Multiple administrations-CG-BM1- 1.0 × 10^6 cells/kg |
| 2.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesCG-BM1 | Biological | Multiple administrations-CG-BM1- 2.0 × 10^6cells/kg |
| 3.0 × 10^6 cells/kg once every two weeks for a total of 3 dosesCG-BM1 | Biological | Multiple administrations-CG-BM1- 3.0 × 10^6cells/kg |
| Placebo, once every two weeks for a total of 3 doses.Placebo | Biological | Placebo |
Primary outcome
Incidence of DLT
Time frame: Single administration: 21 days after dosing Multiple administration: 14 days after the last dose
Incidence of CG-BM1-related AEs and SAEs
Time frame: 12 mouths after the last dose
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 28 Oct 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.
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 single infusion, 1.0 × 10^6 cells/kg, single infusion, 2.0 × 10^6 cells/kg and single infusion, 3.0 × 10^6 cells/kg in people with Ischemic Stroke or High-risk TIA (ABCD² ≥ 4), run by GuangZhou Cellgenes Biotechnology 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 7 inclusion and 21 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 28 Oct 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?
Contact Zeng Liping, Senior Medical Director (+86 20 82514048, Ip.zeng@cellgenes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (time frame: Single administration: 21 days after dosing Multiple administration: 14 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.