Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- safety profile lab tests
研究概览
简要总结
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.
详细描述
Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
排除标准
- •Age > 14 years.
- •Patient weighing < 10 kg.
- •History of severe Allergy
- •History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
- •Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
- •Evidence or history of severe, moderate, or uncontrolled systemic disease.
- •Inability to follow the prescribed dosing and follow-up schedule.
- •Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
- •Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
- •History of premature birth <35 weeks' gestation.
- •Prior history of stroke in utero or other in utero insult.
研究组 & 干预措施
WJMSC
- Patients receive three intravenous doses of MSCs (1 million/kg) every two weeks as treatment.
干预措施: WJMSC (Biological)
结局指标
主要结局
safety profile lab tests
时间窗: follow-up duration is 12 months
-patients will be monitored for any possible adverse events resulting from the injection of MSCs.
次要结局
- efficacy change in Adult ADHD Self-Report Scale (ASRS)(follow-up duration is 12 months)
研究者
Hanan Jafar
Principal investigator
University of Jordan