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

Официальное название

Evaluation of Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Photo-Biomodulation
  Application at acupuncture points for 20 seconds each week. using 810nm Laser probe
• Биопрепарат Autologous PRP
  IV injection of Autologous Plasma Rich Platelets (PRP) on Days 0, 15, 30, and 45.
• Биопрепарат Exosome Therapy
  IV injection of Umbilical Cord-Derived Exosomes at laser acupuncture points Umbilical Cord-Derived Exosomes
• Другое Standard Care (in control arm)
  Routine conventional including Applied Behavioral Analysis (ABA) for Autism Spectrum Disorder (ASD)

Первичные конечные точки

• Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Срок оценки: Baseline]
• Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Срок оценки: 12 Weeks]
• Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Срок оценки: 6 Months]
• Change in Childhood Autism Rating Scale (CARS) Score (15-60) [Срок оценки: 1 Year]

Вторичные конечные точки (4)

• Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Срок оценки: Baseline]
• Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Срок оценки: 12 Weeks]
• Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Срок оценки: 6 Months]
• Assessment of Social Interaction using Autism Diagnostic Observation Schedule (ADOS) [Срок оценки: 1 Year]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Iffat Anwar Medical Complex — Lahore

Идентификаторы

NCT: NCT06600529 · IAMC004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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