NCT06600529

Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder

Evaluation of Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Iffat Anwar Medical Complex · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	Photo-Biomodulation	Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
BIOLOGICAL	Autologous PRP	IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
BIOLOGICAL	Exosome Therapy	IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
OTHER	Standard Care (in control arm)	Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-06-10
• Completion: 2025-12-13
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Pakistan