Could stem cell exosomes help stroke patients recover?
NCT ID NCT06138210
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This early-stage trial tests whether exosomes from stem cells can help people recover from a recent stroke. 29 participants will receive either the exosome treatment or a placebo, and researchers will check for safety and any signs of improved function. The study is small and exploratory, so the main goal is to see if the approach is safe enough to test further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exosomes from human induced pluripotent stem cells (GD-iExo-003)
- What this could lead to
- If it works, this could point toward a new treatment to improve recovery and reduce disability after a stroke.
- What could go wrong
- This is a very early, small study (29 people) focused mainly on safety, not proof of effectiveness. The treatment may not work better than placebo, and side effects are unknown.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
29 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
-
May 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Clinical diagnosis of acute ischemic stroke * Age 18-70 years, inclusion of both genders * Modified Rankin Scale score before stroke of 0-1 * NIHSS score 6-20 at inclusion that did not change by ≥4 points from screening to baseline assessment. * Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. * Confirmation of hemispheric cortical infarct with magnetic resonance imaging or computed tomography * Subjects who received intravenous thrombolysis or underwent mechanical reperfusion are eligible if they meet all other eligibility criteria. * Adequate hepatic and renal function: serum aspartate aminotransferase ≤2.5× upper limit of normal; serum alanine aminotransferase ≤2.5× upper limit of normal; blood urea nitrogen ≤1.25× upper limit of normal; serum creatinine ≤1.25× upper limit of normal * Adequate cardiac function. * Subjects or legal representative can sign the informed consent and must be willing and able to comply with all aspects of treatment and follow-up schedule. Exclusion Criteria: * Presence of intracranial hemorrhage on CT including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage or hemorrhagic transformation, etc. * Presence of a lacunar or a brainstem infarct as the etiology of current symptoms. * Evidence of brain tumor or history of epilepsy or traumatic brain injury. * Subjects with present malignant disease. * Subjects with severe comorbidities including immunodeficiency or coagulation disorders. * Subjects with Alzheimer's disease, Parkinson's disease or other degenerative neurological disease. * Ongoing systemic infection, severe local infection or taking immunosuppressants. * Subjects with positive hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, positive hepatitis C antibody, positive syphilis antibody or HIV * Allergy to the study products. * Documented allergies * Participation in any clinical trial in the last 3 months * Inability or unwillingness to comply with the study schedule * Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible), oe breast feeding * Other serious medical or psychiatric illness that is not adequately controlled * Other circumstances that the investigator considers inappropriate for participation in the trial.
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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.
Contacts and locations
Locations
-
Xuanwu Hospital, Capital Medical University
Beijing, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
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- Can tiny neural exosomes help the brain heal after a severe stroke?