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.
• 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
• 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
Parallel
Photo-Biomodulation
DeviceApplication at acupuncture points for 20 seconds each week. using 810nm Laser probe
Autologous PRP
Biological/VaccineIV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
Exosome Therapy
Biological/VaccineIV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
Standard Care (in control arm)
Other interventionRoutine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)
Change in Childhood Autism Rating Scale (CARS) Score (15-60)
Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Change in Childhood Autism Rating Scale (CARS) Score (15-60)
Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Change in Childhood Autism Rating Scale (CARS) Score (15-60)
Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Change in Childhood Autism Rating Scale (CARS) Score (15-60)
Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
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