Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study

Обзор

This 24-month study is testing whether adding AdiaVita, an umbilical cord blood-derived stem cell and exosome product, to glutathione therapy helps improve autism symptoms in children ages 3-12 more than glutathione alone. Children will be randomly placed into one of two groups for the first three months: one group receives glutathione only, and the other receives glutathione plus monthly intravenous AdiaVita infusions. Both groups also use topical glutathione cream twice daily at home. Autism symptoms will be tracked over two years using the Autism Treatment Evaluation Checklist (ATEC) filled out by parents and by therapists or teachers. Safety, side effects, quality of life, and overall well-being will be closely monitored through regular clinic visits, physical exams, blood tests, and adverse event reporting. After the initial three-month phase, children who received glutathione alone may cross over to receive AdiaVita infusions at no additional cost if safety checks at month 6 are satisfactory. Approximately 100 children with a confirmed autism diagnosis from the Central Florida area will take part. Participation is completely voluntary, and families may withdraw at any time.

Подробное описание

This study evaluates the safety and preliminary effectiveness of AdiaVita, an umbilical cord blood-derived stem cell and exosome product, when combined with glutathione for improving symptoms of Autism Spectrum Disorder in children ages 3-12. Participants are randomized to receive either glutathione alone or glutathione plus AdiaVita during the initial three-month treatment phase. Symptoms are measured using repeated Autism Treatment Evaluation Checklist assessments completed by both parents and therapists/teachers throughout the 24-month follow-up period. The primary outcome is change in total ATEC scores at Month 6, with secondary outcomes including safety, tolerability, quality of life, and overall wellness. Children in the glutathione-only group may enter a Phase II extension in which they later receive stem cell infusions at no additional cost if safety requirements are met at the six-month interim review. All clinical visits include physical exams, vitals, adverse event reviews, and post-infusion monitoring. Treatments involve monthly intravenous administration and twice-daily at-home topical glutathione during Phase One. Blood tests are completed prior to key visits to ensure medical stability, and serious adverse events trigger immediate medical attention and reporting. Risks include infusion-related discomfort, headache, fever, allergic reactions, or rare immune responses, with theoretical long-term risks noted. Potential benefits include improvement in social interaction, communication, and behavioral symptoms, although no benefits are guaranteed. Participation is voluntary and families may withdraw at any time, though study costs already paid are non-refundable. Data are stored securely with coded identifiers and only authorized parties may access identifiable information. Recruitment occurs through direct contact, clinic advertising, community outreach, and social media. Approximately 100 children Nation Wide are expected to participate and must have a confirmed ASD diagnosis prior to enrollment. Exclusion criteria include severe allergies to the study products, uncontrolled medical conditions, and recent participation in another interventional trial. No monetary incentives are offered, and families instead pay a fixed fee of $12,000 for Phase One, which covers all procedures and also includes Phase II if applicable. Outcomes will contribute to scientific knowledge regarding the safety and possible clinical utility of stem cell-based therapies for ASD.

Вмешательства

• Биопрепарат Umbilical Cord Blood-Derived Stem Cells and Exosomes
  Intravenous infusion of cryopreserved allogeneic umbilical cord blood-derived product containing viable mononuclear cells (including hematopoietic and mesenchymal stem/stromal cells) and exosomes.
• Препарат Glutathione
  Reduced L-glutathione administered Intravenous infusion once monthly for 3 months (Phase I)

Первичные конечные точки

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 6 [Срок оценки: Baseline and Month 6]

Вторичные конечные точки (3)

• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Month 3 [Срок оценки: Baseline and Month 3]
• Change from Baseline in Total Autism Treatment Evaluation Checklist (ATEC) Score at Months 12 and 24 [Срок оценки: Baseline, Month 12, and Month 24]
• Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events [Срок оценки: Baseline through Month 24]

Критерии участия

Критерии включения

• Age 3-12 years
• Confirmed ASD diagnosis (DSM-5 criteria, supported by ADOS-2)
• Parent/guardian willingness to consider experimental treatments and comply with study requirements
• Ability to attend all scheduled visits
• Able to meet study cost requirements ($12,000 study fee plus bloodwork costs, if applicable) as described in the informed consent

Критерии исключения

• Severe allergies to study products
• Significant uncontrolled medical conditions
• Pregnancy or breastfeeding (if applicable)
• Participation in another interventional trial within 30 days
• Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Adia Med Of Winter Park — Winter Park

Идентификаторы

NCT: NCT07304440 · Adia Med ASD Research Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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