Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photo-Biomodulation, Autologous PRP, Exosome Therapy, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder: a Randomized Controlled Trial
Overview
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
- 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)
Primary outcome measures
- Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Time frame: Baseline]
- Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Time frame: 12 Weeks]
- Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Time frame: 6 Months]
- Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Time frame: 1 Year]
Secondary outcome measures (4)
- Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Time frame: Baseline]
- Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Time frame: 12 Weeks]
- Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Time frame: 6 Months]
- Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Time frame: 1 Year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Iffat Anwar Medical Complex — Lahore
Identifiers
NCT: NCT06600529 · IAMC004