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

September 16, 2024 updated by: Iffat Anwar Medical Complex

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Iffat Anwar Medical Complex
        • Contact:
        • Contact:
          • Shahzad Anwar, MBBS, DOM
        • Contact:
          • Muhammad Hassan, MBBS, FIPP
        • Contact:
          • Sulayman Waquar, M.Phil, PhD (Scholar)
        • Contact:
          • Gull a Rukh Shaukat, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group

Standard Care:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
12 Weeks
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.
6 Months
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.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
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)
12 Weeks
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)
6 Months
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)
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iffat Anwar Medical Complex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

December 13, 2025

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAMC004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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