Plain-English translation of NCT05003960 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This trial is testing cultured allogeneic adult umbilical cord derived mesenchymal stem cells — cells grown from donated umbilical cord tissue — given as a single intravenous infusion for people with autism. Researchers want to learn whether this treatment is safe and whether it may help improve symptoms of autism. You would receive one infusion containing 100 million cells and then be monitored over four years to see how you respond.
Early research suggests that stem cell treatment might be safe and beneficial for autism, but more studies are needed to confirm this. This trial aims to carefully evaluate whether this type of cell therapy is truly safe for patients and whether it shows promise as a treatment option.
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You would visit the research clinic about one month before receiving the treatment for baseline testing. Then you would receive a single intravenous infusion of the stem cells. After that, you would return for follow-up visits at 1 month, 6 months, 12 months, 24 months, 36 months, and 48 months after your infusion so researchers can check your safety and see whether the treatment is helping your autism symptoms.
AI-generated summary from trial data · Jun 26, 2026 · Not medical advice
Antigua and Barbuda
Greece
Phase
Safety & dosing
Sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Enrollment target
~15 participants
Started
January 2022
Primary completion
December 2027
Last updated on clinicaltrials.gov in April 2025.
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