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New treatment option for Acute Ischemic Stroke
Official title Human Placenta-derived 3D Mesenchymal Stem Cells(Guojianqingke)
ClinicalTrials.gov ID: NCT07635758
What this study is testing
What is Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke)?
Human Placenta-derived 3D Mesenchymal Stem Cells (Guojiangqingke) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I/IIa clinical trial evaluating human placental-derived 3D mesenchymal stem cell (MSC) injection in patients with acute ischemic stroke (AIS). Phase I is a single-dose escalation study to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥18 years and ≤80 years; any gender
- Body weight 45-90 kg
- Diagnosed with acute ischemic stroke, with onset between 6 and 72 hours (inclusive) prior to enrollment; received thrombolysis or not planned for...
- NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) \<2
- Participant or legally authorized representative able to understand and provide written informed consent
You likely can't join if
- Significant pre-stroke disability (pre-stroke modified Rankin Scale [mRS] score ≥2)；
- History of intracerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after this ischemic stroke (imaging re-evaluation before...
- Uncontrolled systemic diseases, including but not limited to: hypertension (systolic BP \>180 mmHg and/or diastolic BP ≥120 mmHg), diabetes (diabetic...
- History of seizure (except secondary epilepsy not currently requiring drug treatment)
- History of brain tumor or malignancy within the past 5 years, including concurrent second primary malignancy, except: a) radically excised...
- History of any of the following:
See the full eligibility criteria
- Age ≥18 years and ≤80 years; any gender
- Body weight 45-90 kg
- Diagnosed with acute ischemic stroke, with onset between 6 and 72 hours (inclusive) prior to enrollment; received thrombolysis or not planned for thrombolysis and no planned thrombectomy
- NIHSS score 6-20, with NIHSS item 1a (Level of Consciousness) \<2
- Participant or legally authorized representative able to understand and provide written informed consent
- Significant pre-stroke disability (pre-stroke modified Rankin Scale [mRS] score ≥2)；
- History of intracerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after this ischemic stroke (imaging re-evaluation before planned dosing shows new bleeding within the infarct area accompanied...
- Uncontrolled systemic diseases, including but not limited to: hypertension (systolic BP \>180 mmHg and/or diastolic BP ≥120 mmHg), diabetes (diabetic acute complications such as ketoacidosis, hyperosmolar hyperglycemic...
- History of seizure (except secondary epilepsy not currently requiring drug treatment)
- History of brain tumor or malignancy within the past 5 years, including concurrent second primary malignancy, except: a) radically excised non-melanoma skin cancer; b) radically treated cervical carcinoma in situ; c)...
- History of any of the following:
- Active or uncontrolled autoimmune disease (e.g., antiphospholipid antibody syndrome)
- Protein C or protein S deficiency
- Sickle cell anemia
- Deep vein thrombosis
- Pulmonary embolism
- Cerebrovascular malformation (e.g., moyamoya disease)
- Any concomitant disease or physical condition (e.g., severe arthritis, amputation, blindness, severe disability from prior stroke) that, in the investigator's judgment, would significantly interfere with accurate...
- Major surgery within the past 30 days (e.g., thoracotomy, cardiac surgery, abdominal surgery, intracranial surgery)
- Currently severe illness, including:
- Severe heart failure (NYHA Class III-IV)
- Severe febrile illness (any fever within 14 days before dosing requiring systemic anti-infective treatment)
- Primary or secondary immunodeficiency disease, or long-term or recent high-dose immunosuppressant or systemic corticosteroid therapy before screening
- Hemorrhagic disorder or bone marrow transplantation
- Any comorbidity that the investigator believes may shorten survival or limit ability to complete the study
- Uncontrolled depression affecting daily life before stroke, dementia that may affect clinical assessment, or other neurological or psychiatric disorders that the investigator believes may affect study assessment
- Uncontrolled active infection; or systemic anti-infective treatment within 7 days before dosing that the investigator assesses may shortly convert to uncontrolled active infection
- Organ function meeting any of the following: Hematology: Absolute neutrophil count (ANC) \ 2.5×ULN Aspartate aminotransferase (AST) \>2.5×ULN Total bilirubin (TBIL) \>1.5×ULN Creatinine \>1.5×ULN Coagulation: Phase I...
- Clinically significant uncorrected electrolyte disturbances (e.g., hyperkalemia, hypernatremia) that the investigator believes may affect study assessment
- Unable to undergo head CT/MRI for any reason (e.g., cardiac pacemaker, metal implants, claustrophobia)
- History of drug abuse or alcohol abuse within the past year
- Allergy to bovine or porcine products, human serum albumin products, or known allergy to gentamicin
- Participation in another investigational drug, device study, or stem cell/immune cell therapy within 3 months before treatment
- History of blood transfusion or vaccination with attenuated/live vaccine within 3 months before screening
- Pregnant or lactating women; or participants with pregnancy plans during the study period, or unwilling to use effective contraception; or females of childbearing potential with positive pregnancy test; or female...
- Other reasons deemed by the investigator as unsuitable for participation or inability to complete study procedures (e.g., lack of willingness)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.