RecruitingNot ApplicableNCT06600529

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

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


Sponsor

Iffat Anwar Medical Complex

Enrollment

100 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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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Interventions

DEVICEPhoto-Biomodulation

Application at acupuncture points for 20 seconds each week. using 810nm Laser probe

BIOLOGICALAutologous PRP

IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.

BIOLOGICALExosome Therapy

IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes

OTHERStandard Care (in control arm)

Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)


Locations(1)

Iffat Anwar Medical Complex

Lahore, Punjab Province, Pakistan

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NCT06600529


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