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

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Standard Care (in control arm); Device: Photo-Biomodulation; Biological: Autologous PRP; Biological: Exosome Therapy

• Registration Number: NCT06600529
• Lead Sponsor: Iffat Anwar Medical Complex

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.

Study Timeline

• Study Start: 2024-08-13
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-06-10
• Study Completion: 2025-12-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard Care (in control arm)	Standard Care: Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines.
Experimental Group	Photo-Biomodulation	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.
Experimental Group	Autologous PRP	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.
Experimental Group	Exosome Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Childhood Autism Rating Scale (CARS) Score (15-60)	1 Year	Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.

Secondary Outcome Measures

Name	Time	Method
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)	1 Year	It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)

Trial Locations

Locations (1)

Iffat Anwar Medical Complex; 🇵🇰 Lahore, Punjab, Pakistan