Autism Spectrum Disorder and Exosomes and extracellular vesicles: what the trial registry contains
The ClinicalTrials.gov registry holds 5 records for exosomes in Autism Spectrum Disorder: 4 recruiting now, 0 labelled Phase 3 or 4, across 4 countries. Snapshot 2026-08-29.
Why this is studied in Autism Spectrum Disorder
Autism is a neurodevelopmental difference, not a lesion to repair, and that framing gap sits under every commercial offer. Registered studies typically test whether immune modulation changes specific behavioural measures. Development itself produces change over months, which is why uncontrolled reports of improvement in children are the least informative data in this entire field.
What exosomes means in this table
Exosome and extracellular-vesicle products are cell-free: vesicles harvested from cultured cells and given without the cells themselves. They are attractive commercially because they avoid live-cell logistics, and they are regulatorily contested for the same reason — several regulators have issued explicit warnings about unapproved exosome products marketed for human use.
The numbers
Every figure below comes from one reproducible query (autism spectrum disorder x exosome) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 5 |
| Interventional studies in the sample | 4 |
| Recruiting right now | 4 |
| Completed | 0 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 or Phase 4 records | 0 |
| Countries with at least one site | 4 |
| Median planned enrolment | 100 participants |
| Largest single planned enrolment | 100 participants |
| First / most recent start year | 2024 — 2026 |
How mature is this evidence?
The registrations are early-phase throughout, though 4 of 5 are open now — worth re-checking rather than treating as settled either way.
The delivery record matters as much as the count: 0 completed against 0 abandoned or suspended, or 0% of everything registered.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 3 | 43% |
| Phase 2 | 2 | 29% |
| Not applicable | 2 | 29% |
Median planned enrolment is 100 participants (largest single study: 100). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
Across 4 countries with registered sites, United States dominates at roughly 40% — a concentration driven by funding and regulation rather than by clinical outcome.
| Country | Studies with a site there |
|---|---|
| United States | 2 |
| Pakistan | 1 |
| China | 1 |
| Mexico | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Sponsorship leans commercial: 1 of the most frequent lead sponsors read as academic or hospital entities and 4 as companies. Who pays shapes what gets measured and what gets published.
- Greater Atlanta Integrative Pediatrics — 1 record
- Adia Med of Winter Park LLC — 1 record
- Iffat Anwar Medical Complex — 1 record
- Dongfang People's Hospital — 1 record
- Healing Hope International — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT07304440 — Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study | Phase 1, Phase 2 | Recruiting | 100 | Adia Med of Winter Park LLC | 2026-05-01 |
| NCT07243561 — Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism | Phase 1, Phase 2 | Recruiting | 60 | Dongfang People's Hospital | 2025-09-01 |
| NCT07622316 — GAIP ASD Research Study | Phase 1 | Recruiting | 100 | Greater Atlanta Integrative Pediatrics | 2026-06-01 |
| NCT06600529 — Combined Photo-Biomodulation At Acupuncture Points, Autologous PRP, and Umbilical Cord-Derived Exosome Therapy in Autism Spectrum Disorder | n/a | Recruiting | 100 | Iffat Anwar Medical Complex | 2024-08-13 |
| NCT07521384 — Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy | n/a | Enrolling By Invitation | 36 | Healing Hope International | 2026-06-01 |
What this page does and does not tell you
These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many exosomes studies for Autism Spectrum Disorder are recruiting right now?
4 of 5 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is exosomes an approved treatment for Autism Spectrum Disorder?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 5 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on exosomes for Autism Spectrum Disorder?
0 of 5 records carry a Phase 3 or Phase 4 label and 0 are marked completed. Registrations run from 2024 to 2026.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Autism Spectrum Disorder: cell-therapy evidence and registered trials
- How much does stem cell therapy for Autism Spectrum Disorder cost? (2026)
- Autism Spectrum Disorder stem cell therapy — your questions answered (2026)
- Autism Spectrum Disorder: cell-therapy evidence by therapy class
- MSC vs exosomes for Autism Spectrum Disorder: what the registries show
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.