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New treatment option for Moyamoya Disease
Official title Treatment of Moyamoya Disease With iPSC-derived Exosomes
ClinicalTrials.gov ID: NCT07065409
What this study is testing
What is iPSC-EVs?
iPSC-EVs is an investigational medicine, being studied as a potential treatment for moyamoya disease.
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
- Moyamoya disease is a cerebrovascular disease clinically characterized by chronic progressive stenosis or occlusion at the ends of bilateral internal carotid arteries and the origin of anterior cerebral arteries and middle cerebral arteries, followed by the formation of abnormal vascular networks at the base of the skull. Clinically, patients with Moyamoya disease mainly present with ischemic or hemorrhagic stroke, and there are two peaks of incidence in children aged 3-5 and middle-aged people aged 40-50.
- Phase 1: an early, usually small safety study
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
- Diagnosed adult patients with MMD aged 18-75 years (inclusive), with bilateral terminal occlusion of the internal carotid arteries (ICA) and stenosis...
- Relevant bone marrow, liver, kidney, and heart function indicators meet the following standards (based on the normal values of the clinical trial...
- Patients have undergone temporal muscle patch surgery and have not achieved satisfactory improvement in symptoms.
- Patients have been followed up for ≥ 3 months since the surgery.
- Vascular DSA performed 3 months after the surgery indicates poor blood flow reconstruction.
You likely can't join if
- Patients with severe liver or kidney dysfunction or other complications;
- Patients with a history of mental disorders or mental diseases;
- Patients with coagulation disorders;
- Patients with extensive cerebral infarction or in a coma;
- Patients who only undergo direct bypass surgery;
- Patients who have not signed the surgical consent form;
See the full eligibility criteria
- 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...
- 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 ≥...
- Patients have undergone temporal muscle patch surgery and have not achieved satisfactory improvement in symptoms.
- Patients have been followed up for ≥ 3 months since the surgery.
- Vascular DSA performed 3 months after the surgery indicates poor blood flow reconstruction.
- CTP or ASL performed 3 months after the surgery shows ischemia.
- Patients still have clinical manifestations of cerebral ischemia or cerebral infarction due to MMD 3 months after the surgery.
- Patients or their legal representatives have given informed consent and signed the informed consent form.
- Patients with severe liver or kidney dysfunction or other complications;
- Patients with a history of mental disorders or mental diseases;
- Patients with coagulation disorders;
- Patients with extensive cerebral infarction or in a coma;
- Patients who only undergo direct bypass surgery;
- Patients who have not signed the surgical consent form;
- Patients with allergic constitutions or a clear history of allergies;
- Pregnant women, lactating women, and patients with plans to conceive during the trial period;
- Patients who have participated in other clinical trials in the past three months;
- Patients deemed unsuitable for the trial by the researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 - 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?
Study sites include Wuhan, Hubei, 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.