Infusion of stem cells for treating autism
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05003960 · Data updated 2026-11-12
This study is testing whether an infusion of stem cells from umbilical cords can help improve symptoms in people with autism.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | January 23, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05003960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with Autism who meet the inclusion criteria.
✕Probably not a fit
Patients with active infections, cancer, or other significant medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells in patients diagnosed with Autism. Participants will receive a single infusion of 100 million stem cells and will be monitored for safety and efficacy at various intervals over a period of 48 months. The study aims to evaluate the potential benefits of stem cell treatment in improving symptoms associated with Autism.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals with Autism, potentially improving their symptoms and quality of life.
How similar studies have gone: Previous studies have indicated that stem cell treatments may be safe and effective for Autism, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Autism Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety * Previous organ transplant * Seizure disorder * Hypersensitivity to sulfur
Where it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.