Intracavitary Injection of Human Umbilical Cord Mesenchymal Stem Cells in Acute Basal Ganglia Hematoma After Stereotactic Aspiration: a Randomized, Single-blind, Placebo-Controlled, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Barthel Index (BI) to evaluate the self-care ability
研究概览
简要总结
A study to examine the safety and potential effectiveness of human umbilical cord mesenchymal stem cells (hUMSCs) in adults who have suffered spontaneous cerebral hemorrhage in basal ganglia. The hypothesis is that hUMSCs will be safe and can improve neurological function after intracerebral hemorrhage so that improve the prognosis of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The hUMSCs suspension and placebo solvent have different appearance so only the participants but not the researches can be masked.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength≤grade
- •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.
排除标准
- •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.
结局指标
主要结局
Barthel Index (BI) to evaluate the self-care ability
时间窗: 3 months
The Barthel index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility including: help needed with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, bathing, presence of absence of fecal incontinence and urinary incontinence. Each performance item is rated on this scale with a given number of points from 0 to 10 or 0 to 15. Item scores are summed to a total score ranging from 0 to 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence. Totally dependent ranges from 0 to 20, severe dependent ranges from 21 to 60, moderate dependent ranges from 61 to 90, mild dependent ranges from 91 to 99, and 100 indicates completely independent.
Frequency of dose limiting adverse events
时间窗: 3 days
Modified Rankin Scale (mRS) to measure the prognosis
时间窗: 3 months
The Modified Rankin Scale (mRS) measures independence rather than performance of specific tasks. Scale consists of six grades from 0 to 5; 0 denotes no symptoms and 5 indicates severe disability. For clinical purpose, mild disability range is from 0 to 2; moderate disability ranges from 3 to 4 and 5 indicates severe disability.
National institute of Health Stroke Scale (NIHSS) to measure stroke recovery
时间窗: 3 months
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment scale used to measure stroke severity. The NIHSS includes the following domains: level of consciousness, eye movements, integrity of visual fields, facial movements, arm and leg muscle strength, sensation, coordination, language, speech and neglect. Each impairment is scored on an ordinal scale ranging from 0 to 2, 0 to 3, or 0 to 4. Item scores are summed to a total score ranging from 0 to 42 (the higher the score, the more severe the stroke).
Rate of muscle strength level of the hemiplegic limb
时间窗: 3 months
次要结局
- Mortality rate(12 months)
- Change in Glasgow coma scale (GCS) score(1 month)
- MRI (T1, T2, Flair, DWI) scanning(12 months)
- Change in Glasgow outcome scale (GOS) score(12 months)