A Phase 1/2 interventional study of single infusion, 1.0 × 10^6 cells/kg and single infusion, 2.0 × 10^6 cells/kg in Ischemic Stroke or High-risk TIA (ABCD² ≥ 4), sponsored by GuangZhou Cellgenes Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by GuangZhou Cellgenes Biotechnology Co., Ltd. · Phase 1/2, Interventional, and Treatment
Biological: single infusion, 1.0 × 10^6 cells/kg · Biological: single infusion, 2.0 × 10^6 cells/kg · Biological: single infusion, 3.0 × 10^6 cells/kg · Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: Placebo, once every two weeks for a total of 3 doses.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 87 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →GuangZhou Cellgenes Biotechnology Co., Ltd. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: single infusion, 1.0 × 10^6 cells/kg
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.
Biological: single infusion, 2.0 × 10^6 cells/kg
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.
Biological: single infusion, 3.0 × 10^6 cells/kg
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.
Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses
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.
Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses
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.
Biological: 3.0 × 10^6 cells/kg 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.
Biological: Placebo, once every two weeks for a total of 3 doses.
CG-BM1
CG-BM1
CG-BM1
CG-BM1
CG-BM1
CG-BM1
Placebo
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
Started Sep 2024 (actual). Primary completion is estimated for Dec 2028, 51 months after the start.
Of 27 phase 1/2 interventional studies under Ischemic Stroke, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 51 months is above that.
How these figures are worked out, and which studies are left out of them.
Biological: single infusion, 1.0 × 10^6 cells/kg · Biological: single infusion, 2.0 × 10^6 cells/kg · Biological: single infusion, 3.0 × 10^6 cells/kg · Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: Placebo, once every two weeks for a total of 3 doses.
Biological: single infusion, 1.0 × 10^6 cells/kg · Biological: single infusion, 2.0 × 10^6 cells/kg · Biological: single infusion, 3.0 × 10^6 cells/kg · Biological: 1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: 3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses · Biological: Placebo, once every two weeks for a total of 3 doses.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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GuangZhou Cellgenes Biotechnology Co., Ltd.