Evaluation of Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Childhood Autism Rating Scale (CARS) Score (15-60)
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of a combination of photo-biomodulation at acupuncture points, autologous platelet-rich plasma (PRP), and umbilical cord-derived exosome therapy in children with Autism Spectrum Disorder (ASD). The study will compare these interventions against standard care to determine their impact on the severity of autism symptoms, as measured by the Childhood Autism Rating Scale (CARS) and other related markers.
详细描述
The study involves three main interventions:
- Photo-Biomodulation (PBM): PBM will be performed once a week using an 810nm, 210mW laser probe for 20 seconds at each selected acupuncture point.
- Autologous Platelet-Rich Plasma (PRP): PRP will be administered at 0 Day, 15 Day, 30 Day, and at 45th Day ADP-derived autologous PRP.
- Exosome Therapy: Exosomes derived from umbilical cord tissue will be injected intravenously at laser acupuncture points. The PRP-exosome sessions will be repeated at 15 Days, 6 weeks, 12 weeks, and 24 weeks.
The study will run over a period of 6 months, with follow-ups and assessments at each phase. The primary outcome measure will be the change in CARS score, with secondary outcomes including additional ASD markers.
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)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Diagnosis of Autism Spectrum Disorder based on DSM-5 criteria
- •Age 3-12 years
- •Stable on current medications for at least 4 weeks prior to study entry
- •Parents or legal guardians willing to provide informed consent
排除标准
- •• Severe comorbid medical conditions
- •Prior stem cell or exosome therapy
- •History of hypersensitivity to any component of the interventions
- •Inability to comply with study procedures
研究组 & 干预措施
Control Group
Standard Care:
Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines.
干预措施: Standard Care (in control arm) (Other)
Experimental Group
The Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions.
干预措施: Photo-Biomodulation (Device)
Experimental Group
The Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions.
干预措施: Autologous PRP (Biological)
Experimental Group
The Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions.
干预措施: Exosome Therapy (Biological)
结局指标
主要结局
Change in Childhood Autism Rating Scale (CARS) Score (15-60)
时间窗: 1 Year
Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
次要结局
- Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)(1 Year)