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

Iffat Anwar Medical Complex

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Biological: Autologous PRP; Biological: Exosome Therapy; Device: Photo-Biomodulation; Other: Standard Care (in control arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT06600529

IAMC004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Control Group

Experimental group

Description:

Standard Care: Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines.

Treatment:

Other: Standard Care (in control arm)

Experimental Group

Experimental group

Description:

The Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions.

Treatment:

Device: Photo-Biomodulation

Biological: Exosome Therapy

Biological: Autologous PRP