Evaluating investigational regenerative medicine approaches under structured medical supervision.
Accepting new participants for quarterly studies.
This investigational study evaluates the application of stem cell and cellular therapies in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). This 12 month, IRB-approved clinical research study aims to improve social interaction, communication, and repetitive behaviors. The study will evaluate using umbilical cord blood-derived stem cells and exosomes, combined with glutathione.
Conducted under structured medical supervision, the study follows defined research protocols to evaluate safety and preliminary observations related to regenerative medicine interventions. All participants undergo comprehensive clinical evaluations before, during, and after the study period.
Hear directly from our Medical Director about what Autism Spectrum Disorder is, our study, and what families should know.
The one-time participation fee includes all investigational procedures, physician and scientific oversight, medications, and stem cell therapies associated with the clinical study. Travel to Orlando is excluded from this cost.
The participation cost may be financed through CareCredit. This flexible payment option allows families to manage the financial aspects of participation. Qualified applicants may be eligible for 0% interest financing for up to 2 years.
If you have a sponsor for the study, please contact our clinical coordination team for information regarding 501(c)(3) nonprofit organization details and sponsorship verification processes.
Every patient is required to complete a pre-treatment Autism Treatment Evaluation Checklist
(ATEC) Assessment and monthly ATEC Assessments for the duration of the study.
ATEC assessments must be completed by:
These assessments must be submitted to the study team before the first treatment and within
five (5) days before or after each monthly clinic visit.
Failure to complete required assessments may result in delays in study procedures or
discontinuation from the study.
ATEC scores are used for research outcome measurement only and are not intended to
replace clinical, educational, or diagnostic evaluations.
STUDY PROCEDURES
If you agree to allow your child to participate in this study, the following will occur:
The following will be completed:
Your child will attend monthly clinic visits for intravenous (IV) infusions lasting approximately 30–60 minutes, followed by 1-2 hours of medical monitoring. Your child will also receive twice-daily topical glutathione spray at home during this phase.
Your child will be randomly assigned (single-blind) to one of two groups. Neither you nor your child will be told which group your child is assigned to during the Treatment Phase.
Assignment does not guarantee improvement.
Treatment Groups:
Note: Arm 2 is a control arm but is not a full placebo, as participants still receive active IV glutathione and the topical glutathione spray. All participants receive IV infusions and twice-daily topical glutathione spray during the Treatment Phase. The only difference between the two arms is the content of the IV infusions (AdiaVita versus saline placebo). Participants will not be told which version of the IV infusion they receive.
Follow-up visits with safety checks and ATEC assessments will occur at Month 6 and Month
12. These visits may be conducted remotely via secure video call when appropriate.
Only participants assigned to Arm 2 may be eligible to receive AdiaVita. If eligible, they will be offered one AdiaVita IV infusion per month for 3 months (at Months 2, 3, and 4) at no
additional cost.
Total Time Commitment
Participants will complete 3 study visits over a defined period. Initial screening includes comprehensive medical evaluations, diagnostic assessments, and baseline measurements. Treatment visits involve the administration of investigational therapies followed by scheduled follow-up appointments to monitor response and safety.
While this is an investigational study, participants may potentially benefit from:
Complete the form below to express interest and learn more about the study.
Complete a comprehensive screening including medical history review and initial assessments.
Our team will review your information and confirm eligibility based on study criteria.
Meet with clinical staff to review the study protocol and sign informed consent documentation.
Begin baseline evaluations and proceed with the investigational treatment protocol.
Study Information
This is a research study testing if a special stem cell treatment (called AdiaVita, made from umbilical cord blood) plus glutathione (a helpful antioxidant) can help children with autism spectrum disorder (ASD). It compares this combo to glutathione alone to see if it makes a difference in symptoms.
Children ages 3 to 12 years old who have a confirmed diagnosis of autism spectrum disorder (ASD). The study plans to include about 100 children. A doctor will check if your child qualifies during screening.
The study runs for 24 months (2 years). Your child would get treatments and check-ups over this time to track any changes.
It's a randomized study, meaning children are randomly placed into one of two groups: Group 1: Gets AdiaVita stem cell infusions + glutathione. Group 2: Gets glutathione alone. Everyone gets glutathione (IV monthly for 3 months + topical cream at home), but only some get the added stem cells. No one knows which group they're in until the study ends (this is called "blinded" to keep results fair). Kids in the glutathione-only group can optionally get AdiaVita later at no extra cost if safety checks pass.
At the Adia Med clinic in Winter Park, Florida.
The study has been approved by an independent Institutional Review Board (IRB from BeyondBound), which checks for safety and ethics. Stem cell treatments are still experimental for autism. The team monitors closely with regular visits, physical exams, blood tests, and adverse event reporting. Risks may include infusion-related issues like discomfort, headache, fever, or allergic reactions (rare). Serious problems are tracked and reported. Broader research on similar stem cell therapies for autism has shown no serious adverse events.
No. This is an investigational research study. It does not claim to cure, treat, or guarantee outcomes for Autism Spectrum Disorder. The study is designed to evaluate regenerative medicine approaches under structured clinical oversight.
Yes. All investigational procedures are conducted under the supervision of licensed medical professionals with experience in regenerative medicine research.
If a participant does not meet the specific criteria for this study, our clinical coordination team can provide information about other available studies or future research opportunities.
The active study period and follow-up timeline will be 6 months. During this time, patients will be expected to make 3-6 monthly trips to our Orlando clinic for treatment and evaluation. Patients are encouraged to remain in the care of their primary physicians and specialists during this time.
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Consultations are confidential and conducted by our Orlando-based
clinical staff - for local and international patients alike.
