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:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT05232903
Eligibility Criteria:
Inclusion Criteria:
1. Age range: 45\~55 years old
2. Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
3. Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative CT.
4. Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
5. Ability to provide written personal or surrogate consent.
6. Expectancy life is longer than 12 months.
7. Subject must be available for all specified assessments at the study site through the completion of the study.
8. Determining Organ function according to the following criteria:
1\) Aspartate transaminase (AST) ≤2.5×Upper limit of normal 2) Alanine transaminase (ALT) ≤2.5×Upper limit of normal 3) Total bilirubin (T-Bil) ≤1.5×Upper limit of normal 4) Serum albumin (SA) ≥3.0g/dL 5) Absolute neutrophil count（ANC）≥1.5×10\^9/L 6) Platelets (PLT) ≥150×10\^9/L 7) Hemoglobin (Hb) ≥9.0g/dL 8) Creatine kinase (CK) ≤1.5×Upper limit of normal 9) Serum amylase (AMY) and serum lipase (Lip) are within the normal range
Exclusion Criteria:
1. Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
2. History of epilepsy.
3. History of brain tumor.
4. History of brain trauma.
5. Pre-existing disability defined as a pre-stroke modified Rankin scale \>2.
6. Evidence of organ failure.
7. Septicemia with high fever and shock.
8. Positive for any one of hepatitis B surface antigens, e antigens, e antibodies, and core antibodies, hepatitis C virus antibodies, syphilis antibodies, or HIV antibodies positive.
9. Participation in any clinical investigation within 3 months prior to dosing.
10. Suffer from any other clinically significant medical diseases or with evidence of metal disorder.
11. The investigator or sponsor determines that participating in the trial will bring safety risks to the patients.
12. Participated in other stem cell therapy research.
13. History of drug or alcohol abuse in the past year
14. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
15. Allergic to cattle and pork products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
55 Years
Study:
NCT05232903
Study Brief:
Protocol Section:
NCT05232903