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

NCT06600529 | Recruiting DMC

• 1 other identifier: IAMC004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

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

  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)

  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)

  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)

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

  1 Year

Secondary Outcomes (4)

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

  Baseline

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

  12 Weeks

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

  6 Months

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

  1 Year

Study Arms (2)

Control Group

EXPERIMENTAL

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)

Experimental Group

EXPERIMENTAL

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; Biological: Autologous PRP; Biological: Exosome Therapy

Interventions

Photo-Biomodulation DEVICE

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

Experimental Group

Autologous PRP BIOLOGICAL

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

Experimental Group

Exosome Therapy BIOLOGICAL

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

Experimental Group

Standard Care (in control arm) OTHER

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

Control Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iffat Anwar Medical Complex: lead

Study Sites (1)

Iffat Anwar Medical Complex

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Shahzad Anwar, MBBS, DOM

CONTACT

0092 0300 9400049; shahzadtirmzi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Estimated Enrollment: 100 Patients * Allocation: Randomized * Intervention Model: Parallel Assignment * Masking: Single (Participant) * Primary Purpose: Treatment

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: August 13, 2024
• Primary Completion: June 10, 2025
• Study Completion: December 13, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

PA (1)