iPSC-derived exosome treatment for Moyamoya disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center Phase 1 interventional trial will deliver induced pluripotent stem cell–derived extracellular vesicles (iPSC-EVs) locally to the temporal muscle in adults with Moyamoya disease to promote angiogenesis. Participants are adults (18–75) with bilateral terminal ICA involvement and Suzuki score ≥3 who have undergone temporal muscle patch surgery without satisfactory improvement. The primary focus is safety and tolerability of the local iPSC-EV transplantation, with exploratory measures of improved muscle and cerebral perfusion. Procedures and follow-up visits will take place at Tongji Hospital in Wuhan.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Huaqiu Zhang — Tongji Hospital
• Study coordinator: Huaqiu Zhang
• Email: lyc@tjh.tjmu.edu.cn
• Phone: 13419632963

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Risk prediction for stroke and cognitive decline in Moyamoya disease and Moyamoya syndrome

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• 5T MRI and Metabolomics to Predict Hemorrhage Risk in Moyamoya Disease

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• XR-assisted CT-guided localization for EC-IC bypass in Moyamoya and chronic cerebral ischemia

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• Family screening and early detection for moyamoya disease

  This project will try to find biological signs and 5T high-resolution MRI features that could detect moyamoya earlier in people with the disease, their first-degree relatives, and people without a family history.

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• Remimazolam: target-controlled infusion versus manual infusion during cerebrovascular bypass

  This trial will test whether target-controlled infusion uses less remimazolam than manual infusion in adults undergoing cerebrovascular bypass surgery for moyamoya disease.

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• Cardiac index–guided blood flow management during pediatric Moyamoya EDAS surgery

  This study will test whether using each child's cardiac index to guide fluids and hemodynamic care during EDAS lowers postoperative transient ischemic episodes in children with Moyamoya disease.

  Recruiting Seoul National University Hospital · Seoul · NCT07304947

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.