Can stem cell vesicles help rebuild brain blood vessels in moyamoya?
NCT ID NCT07065409
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new treatment for Moyamoya disease, a rare condition where major brain arteries narrow, raising stroke risk. The treatment combines a special muscle flap with injections of tiny particles from stem cells (iPSC-EVs) to encourage new blood vessel growth. Nine adults will be monitored for safety and early signs of improved blood flow.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iPSC-derived extracellular vesicles (iPSC-EVs)
- What this could lead to
- If successful, this could lead to a new way to help the brain grow new blood vessels in Moyamoya disease, potentially reducing stroke risk.
- What could go wrong
- This is a very early phase 1 trial with only 9 participants, focused on safety. It is too small to prove effectiveness, and the treatment may not work or could cause 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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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. Diagnosed adult patients with MMD aged 18-75 years (inclusive), with bilateral terminal occlusion of the internal carotid arteries (ICA) and stenosis or occlusion of the anterior cerebral artery (ACA) and middle cerebral artery (MCA) at the origin, accompanied by the formation of abnormal vascular networks at the base of the skull, as indicated by head DSA or MRA. Unilateral or bilateral lesions are acceptable. Suzuki score ≥ 3. 2. Relevant bone marrow, liver, kidney, and heart function indicators meet the following standards (based on the normal values of the clinical trial center): absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT, AST, or ALP ≤ 3 times ULN; serum creatinine ≤ 1.5 times ULN, international normalized ratio (INR) ≤ 1.5 times ULN, APTT ≤ 1.5 times ULN. 3. Patients have undergone temporal muscle patch surgery and have not achieved satisfactory improvement in symptoms. 4. Patients have been followed up for ≥ 3 months since the surgery. 5. Vascular DSA performed 3 months after the surgery indicates poor blood flow reconstruction. 6. CTP or ASL performed 3 months after the surgery shows ischemia. 7. Patients still have clinical manifestations of cerebral ischemia or cerebral infarction due to MMD 3 months after the surgery. 8. Patients or their legal representatives have given informed consent and signed the informed consent form. Exclusion criteria: 1. Patients with severe liver or kidney dysfunction or other complications; 2. Patients with a history of mental disorders or mental diseases; 3. Patients with coagulation disorders; 4. Patients with extensive cerebral infarction or in a coma; 5. Patients who only undergo direct bypass surgery; 6. Patients who have not signed the surgical consent form; 7. Patients with allergic constitutions or a clear history of allergies; 8. Pregnant women, lactating women, and patients with plans to conceive during the trial period; 9. Patients who have participated in other clinical trials in the past three months; 10. Patients deemed unsuitable for the trial by the researcher.
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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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Tongji hospital
RECRUITINGWuhan, Hubei, 430030, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Predicting the unpredictable: new model aims to forecast brain bleeds in moyamoya
- Can a daily pill and a simple physical therapy delay moyamoya strokes?
- Metaverse meets microsurgery: XR platform aims to sharpen brain bypass precision
- French biobank aims to unlock secrets of rare brain vessel diseases
- Your digital twin could help prevent another stroke
- Could a simple MRI and blood test predict moyamoya before it strikes?