Safety of Stromal Vascular Fraction (SVF) Therapy in Patients With Acute Spontaneous Intracerebral Hemorrhage (SICH): a Phase I Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The purpose of this pilot study is to evaluate the safety of stromal vascular fraction (SVF) therapy in patients with spontaneous intracerebral hemorrhage (SICH).
详细描述
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 common neurological emergency with the characteristics of rapid onset, dangerous conditions, and a high disability and fatality rate. Although the fatality rate has decreased, reflecting the progress of recent medical technologies, most patients still have persistent language or limb movement dysfunction.
Stromal vascular fraction (SVF) is a structural framework in the body's fat tissue, comprising mesenchymal stem cells, white blood cells, red blood cells, endothelial cells, T cells, platelets related cytokines. Previous studies have demonstrated that SVF has favorable therapeutic effects against various diseases regarding different systems, including the motor system, respiratory system, circulatory system, and nervous system, which indicated the treatment potential of SVF in the treatment of SICH.
The overall clinical development strategy of this project is to conduct a Phase I dose-escalation study to evaluate the safety of SVF therapy in patients with SICH. Fifteen patients with SICH will be sequentially assigned to 3 dose groups, and the adverse events (AEs) and serious adverse events (SAEs) will be recorded in a period of 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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 >
- •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.
结局指标
主要结局
Occurrence of adverse events
时间窗: 1 year
Number of adverse events at each Stromal vascular fraction (SVF) dose following infusion.
次要结局
- The changes in stroke-related neurologic deficit(baseline, Month 1, Month 3, Month 6, Month 9, Month 12)
- The changes in patients' language function(baseline, Month 1, Month 3, Month 6, Month 9, Month 12)
- The changes in patients' sensorimotor function(baseline, Month 1, Month 3, Month 6, Month 9, Month 12)
研究者
Dr. Yong Cao
Clinical Professor
Beijing Tiantan Hospital