Clinical trial Recruiting at 2 sites Phase 1 Interventional

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

PhasePhase 1
Study typeInterventional
SexAll
Enrollment15 (estimated)
SponsorThe Foundation for Orthopaedics and Regenerative Medicine
Academic / other
Locations2 sites (Naples, Florida and 1 other locations)
StatusRecruiting
StartedJanuary 23, 2022
Main results expectedDecember 1, 2027
Study endsDecember 1, 2027
Registry record updatedOctober 20, 2026
Trial IDNCT05003960 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.