Last updated: February 12, 2022
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Hemorrhage
Stroke
Brain Injury
Treatment
N/AClinical Study ID
NCT05232903
SICH-SVF
Ages 45-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age range: 45~55 years old
- Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12inclusive.
- Stable ICH hematoma volume 60mL or less as measured by ABC2 method based onpreoperative CT.
- Neurosurgical ICH evacuation can be performed within the first 72 h of ICH onset.
- Ability to provide written personal or surrogate consent.
- Expectancy life is longer than 12 months.
- Subject must be available for all specified assessments at the study site through thecompletion of the study.
- Determining Organ function according to the following criteria:
- 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) Serumalbumin (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
- Serum amylase (AMY) and serum lipase (Lip) are within the normal range
Exclusion
Exclusion Criteria:
- Secondary ICH related to aneurysm, AVM, trauma, brain tumor, etc.
- History of epilepsy.
- History of brain tumor.
- History of brain trauma.
- Pre-existing disability defined as a pre-stroke modified Rankin scale >2.
- Evidence of organ failure.
- Septicemia with high fever and shock.
- Positive for any one of hepatitis B surface antigens, e antigens, e antibodies, andcore antibodies, hepatitis C virus antibodies, syphilis antibodies, or HIV antibodiespositive.
- Participation in any clinical investigation within 3 months prior to dosing.
- Suffer from any other clinically significant medical diseases or with evidence ofmetal disorder.
- The investigator or sponsor determines that participating in the trial will bringsafety risks to the patients.
- Participated in other stem cell therapy research.
- History of drug or alcohol abuse in the past year
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Allergic to cattle and pork products.
Study Design
Total Participants: 15
Study Start date:
March 01, 2022
Estimated Completion Date:
September 30, 2024
Study Description
Connect with a study center
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing 100070
ChinaActive - Recruiting

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