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

Last updated: September 16, 2024
Sponsor: Iffat Anwar Medical Complex
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Autism

Asperger's Disorder

Treatment

Photo-Biomodulation

Autologous PRP

Exosome Therapy

Clinical Study ID

NCT06600529
IAMC004
  • Ages 3-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Photo-Biomodulation
Phase:
Study Start date:
August 13, 2024
Estimated Completion Date:
December 13, 2025

Study 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.

Connect with a study center

  • Iffat Anwar Medical Complex

    Lahore, Punjab 54000
    Pakistan

    Active - Recruiting

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