Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600529
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Combined Photo-Biomodulation At Acupuncture Points Autologous PRP and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Biomodulation
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None