Autism Spectrum Disorder and Mesenchymal stem/stromal cells (MSC): what the trial registry contains
The ClinicalTrials.gov registry holds 10 records for MSC in Autism Spectrum Disorder: 4 recruiting now, 0 labelled Phase 3 or 4, across 6 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 MSC means in this table
Mesenchymal stromal cells are the workhorse of commercial cell therapy: easy to source from fat, cord or marrow, easy to expand, and rarely characterised in the same way twice. Their proposed action is paracrine — signalling molecules that damp inflammation — rather than replacement of lost tissue. That matters when reading counts like these, because two studies filed under the same label can test materially different products at different doses by different routes.
The numbers
Every figure below comes from one reproducible query (autism spectrum disorder x mesenchymal stem cell) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 10 |
| Interventional studies in the sample | 10 |
| Recruiting right now | 4 |
| Completed | 4 |
| Terminated, withdrawn or suspended | 0 |
| Phase 3 or Phase 4 records | 0 |
| Countries with at least one site | 6 |
| Median planned enrolment | 46 participants |
| Largest single planned enrolment | 137 participants |
| First / most recent start year | 2009 — 2026 |
How mature is this evidence?
All registered work sits at or below Phase 2, with 4 of 10 studies currently open to enrolment.
Of those, 4 are marked completed and 0 were terminated, withdrawn or suspended — a stop rate of 0%, worth weighing when a clinic quotes 'ongoing research' as reassurance.
| Phase label | Records | Share |
|---|---|---|
| Phase 1 | 9 | 60% |
| Phase 2 | 6 | 40% |
Median planned enrolment is 46 participants (largest single study: 137). 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
6 countries host at least one site. United States is the largest single contributor at roughly 40% of country mentions in this sample.
| Country | Studies with a site there |
|---|---|
| United States | 4 |
| China | 2 |
| Denmark | 1 |
| Panama | 1 |
| Antigua and Barbuda | 1 |
| Greece | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Sponsorship leans commercial: 0 of the most frequent lead sponsors read as academic or hospital entities and 6 as companies. Who pays shapes what gets measured and what gets published.
- Greater Atlanta Integrative Pediatrics — 1 record
- Cell to Cure ApS — 1 record
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. — 1 record
- Translational Biosciences — 1 record
- Adia Med of Winter Park LLC — 1 record
- Black Tie Medical, Inc. — 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 |
| NCT05003960 — Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism | Phase 1 | Recruiting | 15 | The Foundation for Orthopaedics and Regenerative Medicine | 2022-01-23 |
| NCT07546942 — Autism Spectrum Disorder (ASD) Neurodevelopmental Disorder With Issues Social Behavior, Communication Issues, GI Dysfunction. Study is Multimodal Inte | Phase 1, Phase 2 | Enrolling By Invitation | 50 | Black Tie Medical, Inc. | 2026-04-30 |
| NCT04089579 — hCT-MSC in Children With Autism Spectrum Disorder | Phase 2 | Completed | 137 | Joanne Kurtzberg, MD | 2020-10-12 |
| NCT02192749 — Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism | Phase 1, Phase 2 | Completed | 20 | Translational Biosciences | 2014-07 |
| NCT01343511 — Safety and Efficacy of Stem Cell Therapy in Patients With Autism | Phase 1, Phase 2 | Completed | 37 | Shenzhen Beike Bio-Technology Co., Ltd. | 2009-03 |
| NCT07177677 — A Study of Mesenchymal Stem Cell in the Treatment of Autism Spectrum Disorder | Phase 1 | Not Yet Recruiting | 42 | Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. | 2025-09-30 |
| NCT05602116 — ASC - Autism Study | Phase 1 | Completed | 10 | Cell to Cure ApS | 2023-06-09 |
What this page does and does not tell you
A registry is a plan repository. Counting entries tells you what people intended to study, which is a weaker thing than what they found.
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 MSC studies for Autism Spectrum Disorder are recruiting right now?
4 of 10 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is MSC 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. 10 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on MSC for Autism Spectrum Disorder?
0 of 10 records carry a Phase 3 or Phase 4 label and 4 are marked completed. Registrations run from 2009 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.