Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Drug Resistant Epilepsy Single Center, Non-randomized, Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections
研究概览
简要总结
The goal of this clinical trial is to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with epilepsy. The main questions it ams to answer are:
- How is the relationship between secretome therapy and the reduction in seizure frequency and duration in patients with drug-resistant epilepsy in the adult age group?
- How does secretome therapy affect EEG and qEEG results in patients with drug-resistant epilepsy in the adult age group?
- How is the relationship between secretome therapy and the Mini Mental State Examination (MMSE) score in patients with drug-resistant epilepsy in the adult age group?
- How does secretome therapy affect stress levels as measured by the Perceived Stress Scale (PSS) in patients with drug-resistant epilepsy in the adult age group?
- How does secretome therapy affect Gait Deviation Index (GDI) scores in patients with drug-resistant epilepsy in the adult age group?
- How does secretome therapy affect quality of life as measured by the Quality of Life in Epilepsy Inventory (QOLIE-31) in patients with drug-resistant epilepsy in the adult age group?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 to 60 years.
- •Individuals with a clinical diagnosis of epilepsy confirmed by a neurologist based on internationally accepted criteria.
- •Individuals with a seizure frequency of at least 6 times in 12 months.
- •Individuals who have a history of recurrent seizures that are not controlled with standard antiepileptic treatment of at least 2 types of drugs for at least 12 months.
- •Individuals who are in stable general health, without life-threatening acute illnesses or uncontrolled medical conditions.
- •Individuals who do not have a history of other neurodegenerative diseases or severe psychiatric disorders that could affect the results of the study.
- •Individuals who are not pregnant or breastfeeding.
- •Individuals who are willing to provide written consent after receiving complete information about the study.
排除标准
- •Individuals with a history of stroke or evidence of stroke on medical examination.
- •Individuals who have undergone surgery for the treatment of epilepsy.
- •Individuals with a history of allergy or hypersensitivity reactions to the secretome or related components.
- •Individuals with active or uncontrolled autoimmune disease.
- •Individuals receiving immunosuppressive therapy.
- •Individuals with severe hepatic or renal impairment.
- •Individuals with significant vascular or blood vessel disease.
研究组 & 干预措施
Secretome Injection
patient will receive 4 times secretome injection every two weeks for two months
干预措施: Secretome (Drug)
结局指标
主要结局
Changes frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections
时间窗: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Patients achieved a response if there are changes in frequency and duration of the seizures in drugs resistant epilepsy after two months secretome injections.Best outcome when the frequency and duration of the seizures less frequent, worst outcome when the frequency and duration of the seizures get more frequent
Changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results of drugs resistant epilepsy after two months secretome injections
时间窗: From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months
Patients achieved a response if there are changes in EEG and qEEG (Alpha,Beta, Delta, and Theta wave) results in drugs resistant epilepsy after two months secretome injections.Best outcome when the EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a better results, worst outcome when EEG and qEEG (Alpha,Beta, Delta, and Theta wave) get a worse results
次要结局
- Changes in Mini Mental State Examination (MMSE) results of drugs resistant epilepsy after two months secretome injections(From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months)
- Changes in Perceived Stress Scale (PSS) results of drugs resistant epilepsy after two months secretome injections(From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months)
- Changes in Gait Deviation Index (GDI) results of drugs resistant epilepsy after two months secretome injections(From enrollment to the end of treatment at 2 months, From enrollment to the end of study at 8 months)