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

NCT06600529 — Not applicable, Unknown, 100 participants, Iffat Anwar Medical Complex

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Evaluation of Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder: a Randomized Controlled Trial

Registry	NCT06600529, acronym Biomodulation
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	100 (Estimated)
Sponsor	Iffat Anwar Medical Complex (Other)
Conditions	Autism Spectrum Disorder
Interventions	Photo-Biomodulation, Autologous PRP, Exosome Therapy, Standard Care (in control arm) (Device, biological, other)
Dates	start 2024-08-13, primary completion 2025-06-10 (estimated), completion 2025-12-13 (estimated), first posted 2024-09-19, last updated 2024-09-19
Locations	1 site in Pakistan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control Group	Experimental	Other: 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	Experimental	Device: Photo-Biomodulation; Biological: Autologous PRP; Biological: 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.

Photo-Biomodulation (Device): Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
Autologous PRP (Biological): IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
Exosome Therapy (Biological): IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
Standard Care (in control arm) (Other): Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)

+Outcome measures

Primary outcomes

Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Baseline]: Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Change in Childhood Autism Rating Scale (CARS) Score (15-60) [12 Weeks]: Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
Change in Childhood Autism Rating Scale (CARS) Score (15-60) [6 Months]: Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.
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 outcomes

Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Baseline]: It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [12 Weeks]: It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [6 Months]: It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
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)

+Eligibility

Sex: All, ages: 3 Years to 12 Years

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

+Locations (1)

Facility	City	Country	Status
Iffat Anwar Medical Complex	Lahore, Punjab Province	Pakistan	Recruiting