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NCT Number: NCT06600529

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

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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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iffat Anwar Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Gull a Rukh Shaukat, MS

CONTACT

Muhammad Hassan, MBBS, FIPP

CONTACT

Shahzad Anwar

CONTACT

[email protected]

0092 0300 9400049

Shahzad Anwar, MBBS, DOM

CONTACT

Sulayman Waquar, M.Phil, PhD (Scholar)

CONTACT

About this study

The study involves three main interventions:

  • Photo-Biomodulation (PBM): PBM will be performed once a week using an 810nm, 210mW laser probe for 20 seconds at each selected acupuncture point.
  • Autologous Platelet-Rich Plasma (PRP): PRP will be administered at 0 Day, 15 Day, 30 Day, and at 45th Day ADP-derived autologous PRP.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Change in Childhood Autism Rating Scale (CARS) Score (15-60)

    Time frame: Baseline

    Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.

  2. Change in Childhood Autism Rating Scale (CARS) Score (15-60)

    Time frame: 12 Weeks

    Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.

  3. Change in Childhood Autism Rating Scale (CARS) Score (15-60)

    Time frame: 6 Months

    Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.

  4. Change in Childhood Autism Rating Scale (CARS) Score (15-60)

    Time frame: 1 Year

    Range of CARS Score 15-29.5: Non-autistic. 30-36.5: Mild to moderate autism. 37-60: Severe autism.

Secondary outcomes

  1. Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)

    Time frame: 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)

  2. Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)

    Time frame: 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)

  3. Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)

    Time frame: 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)

  4. Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Shahzad Anwar, MBBS, DOM

CONTACT

[email protected]

0092 0300 9400049

Sponsors and collaborators

Lead sponsor

Iffat Anwar Medical Complex

Other

Registry information

Official study title

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

Acronym: Biomodulation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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