Infusion of stem cells for treating autism
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism
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 |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 3 sites (St John's and 2 other locations) |
| Trial ID | NCT05003960 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Autism who meet the inclusion criteria.
Not a fit: Patients with active infections, cancer, or other significant medical conditions may not benefit from this study.
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 performed: Previous studies have indicated that stem cell treatments may be safe and effective for Autism, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
St John's and 2 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Athens Beverly Hills Medical Group — Glyfada, Athens, Greece (Recruiting)
- Mediterraneo Hospital Ilias 8-12 — Glyfada, Athens, Greece (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.