Adia Med Completes Phase 1 and Formally Launches Phase 2 of Autism Spectrum Disorder Clinical Study
Rhea-AI Summary
Adia Med (OTCQB: ADIA) reported completion of Phase 1 treatment for the first cohort of 30 children (ages 3–12) in its Autism Spectrum Disorder clinical study (NCT07304440) and the formal launch of Phase 2 for that cohort.
After Institutional Review Board permission, Adia Med shortened Phase 1 by one month, enabling earlier completion of the initial interventional phase, which began May 1, 2026. The randomized 12‑month Phase 1/2 trial compares AdiaVita (umbilical cord blood‑derived stem cells and exosomes) plus glutathione against glutathione alone, with primary outcomes based on changes in Autism Treatment Evaluation Checklist (ATEC) scores.
New cohorts of 30 children are scheduled every three months, with the next Phase 1 group starting October 1, 2026, under Dr. Thomas. The study targets approximately 100 children, remains fully investigational, and makes no claims of treating, curing, or preventing ASD, according to Adia Med.
Positive
- First cohort Phase 1 completed for 30 ASD children, enabling Phase 2 start
- IRB-approved one-month reduction in Phase 1 duration accelerates trial timeline
- Phase 2 formally launched for first cohort in ASD study NCT07304440
- Staggered enrollment of 30 children every three months supports trial scaling
- Study targets approximately 100 pediatric participants in 12-month randomized design
- Multiple revenue streams from Adia Labs products, clinics, and equity holdings disclosed
Negative
- ASD study remains fully investigational with no approved therapy or efficacy claims
- Clinical trial makes no claims of treatment, cure, or prevention for autism spectrum disorder
AI-generated analysis. How Rhea-AI works. Not financial advice.
Next Cohort of 30 Children to Begin a New Phase 1 Treatment Group on October 1, 2026, as Successive Enrollment Continues Every Three Months
Winter Park, Florida--(Newsfile Corp. - July 29, 2026) - Adia Med Inc. (OTCQB: ADIA) today announced two distinct milestones in its Autism Spectrum Disorder (ASD) clinical research study (ClinicalTrials.gov Identifier: NCT07304440): the completion of Phase 1 treatment for the study's first cohort of children, and the formal launch of Phase 2 of the study. Separately, the company confirmed that a new cohort of 30 children will begin its own Phase 1 treatment on October 1, 2026, as part of the study's ongoing, staggered enrollment schedule.
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Following receipt of permission from the Institutional Review Board (IRB), Adia Med reduced the duration of Phase 1 by one month. This acceleration allowed the study's first cohort of 30 children, ages 3-12 with confirmed ASD diagnoses, to complete the initial interventional phase ahead of the original schedule. Treatment for this first group began on May 1, 2026, and Phase 1 for that cohort is now complete.
The study evaluates the safety and preliminary effectiveness of AdiaVita (umbilical cord blood-derived stem cells and exosomes) combined with glutathione therapy, compared with glutathione alone, with primary outcomes measured by changes in Autism Treatment Evaluation Checklist (ATEC) scores.
With Phase 1 complete for the first cohort, Adia Med formally commenced Phase 2 of the overall study for the first cohort. Phase 2 advances the research protocol first established in Phase 1 and continues to assess safety and preliminary effectiveness across the study population.
Separate from the Phase 2 launch, Adia Med continues to enroll and treat additional cohorts of 30 children every three months, with each new cohort completing its own Phase 1 interventional treatment before advancing. The next cohort of 30 children is scheduled to begin its Phase 1 treatment on October 1, 2026, under the supervision of Dr. Thomas.
"Receiving IRB permission to shorten Phase 1 by one month enabled us to move efficiently while maintaining the highest standards of safety and scientific rigor," said Larry Powalisz, Chief Executive Officer of Adia Med Inc. "Completing the first cohort of 30 children and advancing into Phase 2 is a meaningful step forward. With Dr. Thomas leading Phase 1 groups of 30 children every three months, beginning with the next cohort on October 1, we remain focused on carefully expanding this important research for families affected by autism spectrum disorder."
The overall study is designed as a 12-month randomized, interventional trial aiming to enroll approximately 100 children in total. It remains fully investigational. Participation is voluntary, and families may withdraw at any time. The study continues under ongoing Institutional Review Board oversight and is listed on ClinicalTrials.gov.
The Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study (NCT07304440) is a Phase 1/2 study examining whether the addition of AdiaVita to glutathione therapy may improve symptoms of ASD in children ages 3-12 more than glutathione alone. Secondary endpoints include safety, tolerability, quality of life, and overall wellness.
Adia Med emphasizes that the study makes no claims regarding the treatment, cure, or prevention of autism spectrum disorder. All participants receive close medical monitoring throughout the protocol.
About the Study
The Adia Med of Winter Park LLC Autism Spectrum Disorder Research Study (NCT07304440) is a Phase 1/2 study examining whether the addition of AdiaVita to glutathione therapy may improve symptoms of ASD in children ages 3-12 more than glutathione alone. Secondary endpoints include safety, tolerability, quality of life, and overall wellness.
For questions, inquiries, or additional information, please contact Larry Powalisz at ceo@adiamed.com or by phone at 321-231-2843.
About Adia Med Inc.
(OTCQB: ADIA), headquartered in Winter Park, Florida, is a regenerative medicine company built around active, IRB-approved stem cell therapy studies. Through its Adia Med clinics, the company delivers stem cell treatments alongside complementary services like platelet-rich plasma (PRP), therapeutic plasma exchange (TPE), and autologous hematopoietic stem cell transplantation (aHSCT), supported by multiple Institutional Review Board (IRB)-approved clinical studies, The current studies are targeting autism spectrum disorder, chronic kidney disease, and lower back pain, with more planned for 2026. Its Adia Labs division manufactures regenerative products (AdiaVita, AdiaLink) that supply this clinical work.
Adia Labs generates revenue by manufacturing and selling regenerative products (AdiaVita and AdiaLink) to Adia Med clinics and external providers. Adia Med clinics generate revenue through patient treatments (stem cell therapies, PRP, TPE, and aHSCT). Additional revenue comes from the company's
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