An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Internal Carotid Artery and Intravenously in Patients After Stroke
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
研究概览
简要总结
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?
详细描述
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females between Age 18 and 80 years.
- •Symptoms and signs of clinically definite ischemic stroke or hemorrhagic stroke
- •DWI-MRI has reliably shown relevant ischemic lesions
- •Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability
- •The stroke is severe (NIH Stroke Scale >= 8 before procedure)
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society.
排除标准
- •Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
- •Resting heart rate > 100 bpm;
- •Active clinical infection being treated by antibiotics within one week of enrollment.
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Unwilling and/or not able to give written informed consent.
结局指标
主要结局
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
时间窗: 6 months
Number of participants with adverse events at 3 weeks
时间窗: 3 weeks
Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months
时间窗: 3 months
Number of participants with adverse events
时间窗: 1 week
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Number of participants with adverse events at 2 weeks
时间窗: two weeks
Number of participants with adverse events at 4 weeks
时间窗: 4 weeks
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months
时间窗: 6 months
次要结局
- Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months(3 months)
- Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months(3 months)
- Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months(3 months)
- Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months(6 months)
- Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months(6 months)
- Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months(6 months)