Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration
NCT ID: NCT04074408
Last Updated: 2020-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2020-05-31
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort 1
low dose hUMSCs or high dose hUMSCs
stereotactic surgery
stereotactic aspiration surgery
hUMSCs
single intracavitary infusion 1 day after stereotactic aspiration surgery
Cohort 2
best dose of hUMSCs (from cohort 1) or placebo
stereotactic surgery
stereotactic aspiration surgery
hUMSCs
single intracavitary infusion 1 day after stereotactic aspiration surgery
placebo
single intracavitary infusion 1 day after stereotactic aspiration surgery
Interventions
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stereotactic surgery
stereotactic aspiration surgery
hUMSCs
single intracavitary infusion 1 day after stereotactic aspiration surgery
placebo
single intracavitary infusion 1 day after stereotactic aspiration surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital, University of Science and Technology of China
OTHER
Zhejiang University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
Jinhua Hospital, School of Medicine, Zhejiang University
UNKNOWN
Taizhou Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAHZJU-hUMSCs
Identifier Type: -
Identifier Source: org_study_id
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