Clinical trial NCT06600529: Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Iffat Anwar Medical Complex
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Estimated Enrollment: 100 Patients
* Allocation: Randomized
* Intervention Model: Parallel Assignment
* Masking: Single (Participant)
* Primary Purpose: Treatment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Childhood Autism Rating Scale (CARS) Score (15-60)
timeFrame: Baseline
measure: Change in Childhood Autism Rating Scale (CARS) Score (15-60)
timeFrame: 12 Weeks
measure: Change in Childhood Autism Rating Scale (CARS) Score (15-60)
timeFrame: 6 Months
measure: Change in Childhood Autism Rating Scale (CARS) Score (15-60)
timeFrame: 1 Year
Secondary outcomes:
measure: Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
timeFrame: Baseline
measure: Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
timeFrame: 12 Weeks
measure: Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
timeFrame: 6 Months
measure: Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
timeFrame: 1 Year
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Iffat Anwar Medical Complex
state: Punjab
Study officials:
References: