Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder
NCT ID: NCT06600529
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-08-13
2025-12-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Allocation: Randomized
* Intervention Model: Parallel Assignment
* Masking: Single (Participant)
* Primary Purpose: Treatment
TREATMENT
SINGLE
Study Groups
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Control Group
Standard Care:
Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines.
Standard Care (in control arm)
Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)
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.
Photo-Biomodulation
Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
Autologous PRP
IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
Exosome Therapy
IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
Interventions
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Photo-Biomodulation
Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
Autologous PRP
IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
Exosome Therapy
IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
Standard Care (in control arm)
Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)
Eligibility Criteria
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Inclusion 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
* Prior stem cell or exosome therapy
* History of hypersensitivity to any component of the interventions
* Inability to comply with study procedures
3 Years
12 Years
ALL
No
Sponsors
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Iffat Anwar Medical Complex
OTHER
Responsible Party
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Locations
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Iffat Anwar Medical Complex
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Shahzad Anwar, MBBS, DOM
Role: backup
Muhammad Hassan, MBBS, FIPP
Role: backup
Sulayman Waquar, M.Phil, PhD (Scholar)
Role: backup
Gull a Rukh Shaukat, MS
Role: backup
Other Identifiers
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IAMC004
Identifier Type: -
Identifier Source: org_study_id
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