Status:
UNKNOWN
Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH).
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Spontaneous Intracerebral Hemorrhage
Eligibility:
All Genders
45-55 years
Phase:
PHASE1
Brief Summary
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
Detailed Description
Spontaneous intracerebral hemorrhage (SICH) is a form of brain parenchymal hemorrhage caused by various non-traumatic reasons, resulting in cerebral artery, veins or capillaries rupture. SICH is a com...
Eligibility Criteria
Inclusion
- Age range: 45\~55 years old
- Acute spontaneous supratentorial ICH documented by head CT with GCS Score between 8-12 inclusive.
- Stable ICH hematoma volume 60mL or less as measured by ABC2 method based on preoperative 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 the completion of the study.
- 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
- 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, and core antibodies, hepatitis C virus antibodies, syphilis antibodies, or HIV antibodies positive.
- Participation in any clinical investigation within 3 months prior to dosing.
- Suffer from any other clinically significant medical diseases or with evidence of metal disorder.
- The investigator or sponsor determines that participating in the trial will bring safety 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05232903
Start Date
March 1 2022
End Date
September 30 2024
Last Update
March 2 2022
Active Locations (1)
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1
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100070