Cord stem cells infused for stroke: a new hope?
NCT ID NCT07084012
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests whether stem cells from donated umbilical cords can improve recovery after a recent stroke. About 60 adults who had a stroke within the last 72 hours will receive either one or two infusions of these cells or a placebo. The goal is to see if the treatment helps restore movement and daily function, and to check for any side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 75 years, inclusive, regardless of gender. 2. Diagnosis of acute ischemic stroke (AIS). 3. Onset time ≤ 72 hours. 4. Anterior circulation cerebral infarction. 5. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke. 6. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1. 7. The subject or their legal guardian has signed the informed consent form. Exclusion Criteria: 1. Planned or already undergone thrombolysis or thrombectomy for this stroke. 2. 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 subject's participation in the trial or the assessment of efficacy. 3. Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.). If only petechial bleeding is present, the investigator may determine whether the subject is suitable for inclusion in the study. 4. 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 assesses a high likelihood of surgical intervention or poor prognosis. 5. Presence of brain tumor or history of malignancy. 6. 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 rate (eGFR) \< 60 mL/min/1.73 m². 7. History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial. 8. Severe infection, including sepsis, septic shock, severe pneumonia, etc. 9. Systemic corticosteroid ( \> 10 mg/day prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial. 10. 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 wine). 11. 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. 12. Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion). 13. 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, unacceptable laboratory abnormalities, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100070, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diabetes drug help the brain heal after a stroke?
- Stroke treatment upgrade: adding a Clot-Buster after clot removal may boost recovery
- Gene therapy particles aim to boost stroke recovery
- Balloon catheters may improve stroke clot removal
- Blood test may forecast stroke severity
- Could a single shot boost stroke recovery? new trial aims to find out