Acute Ischemic Stroke AIS study: HUC-MSCs treatment
Official title A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
ClinicalTrials.gov ID: NCT07084012
What this study is testing
What is hUC-MSCs treatment (high dose)?
This is an investigational cell therapy being studied as a potential treatment for acute ischemic stroke.
Also referred to as hUC-MSCs injection.
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 study aims to find out if giving stem cells through an IV improves recovery after an acute ischemic stroke. It also checks if the treatment is safe and how the body handles the cells.
- Who it's for
- People who have recently had an acute ischemic stroke (a stroke caused by a blood clot).
- What's involved
- Participants will receive one or more IV infusions of stem cells or a placebo. They will undergo medical tests to monitor their health and how their body processes the treatment.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. 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 75
You may be able to join if
- Age 18 to 75 years, inclusive, regardless of gender.
- Diagnosis of acute ischemic stroke (AIS).
- Onset time ≤ 72 hours.
- Anterior circulation cerebral infarction.
- Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.
You likely can't join if
- Planned or already undergone thrombolysis or thrombectomy for this stroke.
- History of epilepsy (excluding secondary epilepsy that does not currently require medication), Parkinson's disease, Alzheimer's disease, severe...
- Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural...
- Computed tomography (CT) or magnetic resonance imaging (MRI) of the head showing a large ischemic area in the middle cerebral artery territory or...
- Presence of brain tumor or history of malignancy.
- Liver or kidney insufficiency during the screening period: Aspartate aminotransferase (AST) \> 2.5 × upper limit of normal, alanine aminotransferase...
See the full eligibility criteria
- Age 18 to 75 years, inclusive, regardless of gender.
- Diagnosis of acute ischemic stroke (AIS).
- Onset time ≤ 72 hours.
- Anterior circulation cerebral infarction.
- Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.
- National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.
- The subject or their legal guardian has signed the informed consent form.
- Planned or already undergone thrombolysis or thrombectomy for this stroke.
- History of epilepsy (excluding secondary epilepsy that does not currently require medication), Parkinson's disease, Alzheimer's disease, severe depression, or other diseases that the investigator deems would affect the...
- Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.).
- Computed tomography (CT) or magnetic resonance imaging (MRI) of the head showing a large ischemic area in the middle cerebral artery territory or midline shift greater than 1 cm on head CT/MRI, and the investigator...
- Presence of brain tumor or history of malignancy.
- Liver or kidney insufficiency during the screening period: Aspartate aminotransferase (AST) \> 2.5 × upper limit of normal, alanine aminotransferase (ALT) \> 2.5 × upper limit of normal, estimated glomerular filtration...
- History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial.
- Severe infection, including sepsis, septic shock, severe pneumonia, etc.
- Systemic corticosteroid ( \> 10 mg/day prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial.
- History of alcohol abuse within the past year (defined as an average of more than 2 units per day (1 unit = 10 mL ethanol, i.e., 1 unit = 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol...
- Pregnant or breastfeeding women; or unwillingness to use reliable contraception (e.g., condoms) throughout the study period, or plans to donate sperm or eggs, or have plans for pregnancy.
- Participation in an treatment clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion).
- Other situations in which the investigator deems the patient unsuitable for participation in this study (including but not limited to non-compliance with the principle of patient benefit, poor patient compliance...
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.