Autism Spectrum Disorder
Conditions
Brief summary
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.
Detailed description
The study involves three main interventions: 1. Photo-Biomodulation (PBM): PBM will be performed once a week using an 810nm, 210mW laser probe for 20 seconds at each selected acupuncture point. 2. Autologous Platelet-Rich Plasma (PRP): PRP will be administered at 0 Day, 15 Day, 30 Day, and at 45th Day ADP-derived autologous PRP. 3. 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.
Interventions
DEVICEPhoto-Biomodulation
Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
BIOLOGICALAutologous PRP
IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
BIOLOGICALExosome Therapy
IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
OTHERStandard Care (in control arm)
Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)
Sponsors
Iffat Anwar Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
* Estimated Enrollment: 100 Patients * Allocation: Randomized * Intervention Model: Parallel Assignment * Masking: Single (Participant) * Primary Purpose: Treatment
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* • 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
Exclusion criteria
* • 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Childhood Autism Rating Scale (CARS) Score (15-60) | Baseline | Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) | Baseline | It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism) |
Countries
Pakistan
Contacts
Primary ContactShahzad Anwar, MBBS, DOM
Outcome results
None listed