NCT07065409 Treatment of Moyamoya Disease With iPSC-derived Exosomes
| NCT ID | NCT07065409 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Huaqiu Zhang |
| Condition | Moyamoya Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2025-05-26 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Moreover, as the pathogenesis and treatment evaluation of Moyamoya disease are still in the research trough at present, new discoveries are prone to occur and thus attract a great deal of attention. It not only has a beneficial promoting effect on the treatment and diagnosis of patients, but also makes it easier for research topics to be reported in top journals. This study intends to combine iPSC-EVs local skin transplantation with temporal muscle application to promote muscle angiogenesis and the establishment of extracranial and intracranial collateral circulation after temporal muscle application. The above-mentioned design features high efficiency, safety and convenience, and is an innovative exploration both at home and abroad. We hope to screen out safe, efficient and simple preparation methods and transplantation methods of iPSC-EVs through systematic experiments, establish an effective clinical evaluation system, and provide auxiliary means for intracranial and extracranial blood flow reconstruction surgery in the treatment of Moyamoya disease. Moreover, in terms of topic selection, iPSC is currently one of the most promising directions for innovative treatment worldwide.
Eligibility Criteria
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.
Contact & Investigator
Huaqiu Zhang
PRINCIPAL INVESTIGATOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT07065409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Moyamoya Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07065409 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07065409 currently recruiting?
Yes, NCT07065409 is actively recruiting participants. Contact the research team at lyc@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT07065409 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07065409 clinical trial?
NCT07065409 is sponsored by Huaqiu Zhang. The principal investigator is Huaqiu Zhang at Tongji Hospital. The trial plans to enroll 9 participants.