Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration

This is an interventional treatment trial for Basal Ganglia Hematoma Read More

Inclusion Criteria:

• Male or female participants between 30 and 75 years of age, diagnosed of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume from 10 ml to 60 ml calculated by ABC/2 formula.
• Within 5 days from onset to operation, and no improvement.
• Glasgow Coma Scale (GCS) score of 9 to 15.
• With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength≤grade 3.
• Modified Rankin scale (mRS) score≤1 in past medical history.
• Women of reproductive age have negative pregnancy tests.
• The participants or the legal guardian/representative who are suitable and willing to participate in the clinical trial and can cooperate to complete the follow-ups.

Exclusion Criteria:

• Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation AVM and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
• In the sequela stage of cerebral trauma.
• Hematoma involves other structures including but not limited to the thalamus and midbrain or complicated with intraventricular hemorrhage.
• With neurologic impairment before cerebral hemorrhage onset.
• Participants receiving anticoagulant or antiplatelet therapy.
• The disease progresses quickly. Manifestation of cerebral herniation such as bilateral dilated pupil, disappearance of light reflex, and unstable vital signs.
• Active stage of infectious diseases including but not limited to HIV, hepatitis B, and C.
• History of poorly controlled seizures.
• History of severe co-morbidity (including but not limited to hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment. Coagulation dysfunction INR >1.4, PTT>37 seconds, thrombocytopenia (PLT<8×10^9/L), serum creatinine exceeded the upper limit of normal by 1.4 times, serum ALT >150U/L, and/or serum total bilirubin >1.6mg/dl.
• Participants with a mechanical heart valve. Biological valves are acceptable.
• Participants with a risk of embolism (including but not limited to a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis). Atrial fibrillation without mitral stenosis is acceptable.
• May be pregnant in the near future or already pregnant.
• Enrolled in this clinical trial or participating in other interventional medical research or clinical trials at the same time.
• Participants difficult to follow up or with poor compliance due to various reasons (including but not limited to geographical and social factors, drug or alcohol abuse).
• Participants or the legal guardian/representative is unable or unwilling to give the written informed consent.
• Vulnerable groups (including but not limited to mental retardation, abuse, inability to fully exercise informed consent).
• Any subject that the researchers think is not suitable for enrollment.