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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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