Autism Spectrum DisorderBiomodulationNCT06600529
Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder
A study testing Photo-Biomodulation, Autologous PRP and Exosome Therapy in people with Autism Spectrum Disorder, run by Iffat Anwar Medical Complex at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Photo-Biomodulation, Autologous PRP and Exosome Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Aug 2024to 13 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Iffat Anwar Medical Complex
Lahore, Punjab Province, 54000
Shahzad Anwar, 0092 0300 9400049, shahzadtirmzi@yahoo.com
Shahzad Anwar, MBBS, DOM
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Photo-Biomodulation, Autologous PRP, Exosome Therapy, Standard Care (in control arm)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-BiomodulationDevice
Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
Autologous PRPBiological
IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
Exosome TherapyBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Standard Care:
Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines. Receives: 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. Receives: Device: Photo-Biomodulation; Biological: Autologous PRP; Biological: Exosome Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Year
Secondary outcomes (4)
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Measured: Baseline
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Measured: 12 Weeks
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Measured: 6 Months
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
It have 4 modules each module have 28-30 items each item includes rating 0-3 (0 being normal while 3 specifies severe autism)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start13 Aug 2024
- Primary completion10 Jun 2025 (estimated)
- Study completion13 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Estimated Enrollment: 100 Patients * Allocation: Randomized * Intervention Model: Parallel Assignment * Masking: Single (Participant) * Primary Purpose: Treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iffat Anwar Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600529
- Sponsor's protocol ID
- IAMC004
- Acronym
- Biomodulation
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06600529
- Acronym / sponsor ID
- Biomodulation / IAMC004
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iffat Anwar Medical ComplexUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 13 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Estimated Enrollment: 100 Patients * Allocation: Randomized * Intervention Model: Parallel Assignment * Masking: Single (Participant) * Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Standard Care (in control arm)Standard Care: Procedure: Routine conventional Applied Behavioral Analysis (ABA) management and interventions for ASD, as per current clinical guidelines. |
| Experimental Group | Experimental | Device: Photo-Biomodulation, Biological: Autologous PRP, Biological: Exosome TherapyThe Group may be provided with three interventions and then compared with the control group in order to evaluate the effects of the said interventions. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Diagnosis of Autism Spectrum Disorder based on DSM-5 criteria
Key exclusion criteria (4 listed)
- • Severe comorbid medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo-BiomodulationApplication at acupuncture points for 20 seconds each week. using 810nm Laser probe | Device | Experimental Group |
| Autologous PRPIV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45. | Biological | Experimental Group |
| Exosome TherapyIV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes | Biological | Experimental Group |
| Standard Care (in control arm)Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD) | Other | Control Group |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
Time frame: Baseline
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
Time frame: 12 Weeks
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
Time frame: 6 Months
Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS)
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo-Biomodulation, Autologous PRP and Exosome Therapy in people with Autism Spectrum Disorder, run by Iffat Anwar Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahzad Anwar, MBBS, DOM (0092 0300 9400049, shahzadtirmzi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Childhood Autism Rating Scale (CARS) Score (15-60) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.