Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06752720
Eligibility Criteria:
Inclusion criteria
1. Age between 20 and 70 years
2. Clinical diagnosis of ischemic stroke between 6 months and 5 years ago
3. Ischemic area in the territory of unilateral interanal cerebral artery
4. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
5. Subjects with a DTI-RAINBOW (R-DTI) value of more than 70% at screening MR imaging
6. No significant neurological impairment before the stroke (Pre-stroke mRS of 0 or 1)
7. Subjects who can give informed consent by its self
Exclusion criteria
1. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)"
2. Anaemia (Hg \< 10·0 g/dL)
3. Thrombocytopaenia (platelet count \< 100,000/mm3)
4. Severe heart disease (ischaemic heart disease, heart failure)
5. Severe Systemic organ failure ALT \<3·0× upper limit of normal Total bilirubin \< 1·5× upper limit of normal Serum creatinine \< 1·5× upper limit of normal
6. History of malignancy
7. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
8. Pregnant or lactating or expecting to become pregnant during the study
9. Known serious allergy to any agents used in the study
10. Contraindication for magnetic resonance imaging
11. History of seizure within 2 years
12. Subject's body weight less than 45 kg for male and 40kg for female "13. Participating in another clinical trial within 90 days, or planning to participate in another clinical trial in the future"
14\. Any condition that in the judgement of the investigator would place the patient at undue risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06752720
Study Brief:
Protocol Section:
NCT06752720