Recruiting
Phase 1

Mesenchymal Stem Cells

Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Code:

NCT05003960

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Study Details

Brief summary:

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Autism

Conditions

Autism

Study ID

NCT05003960

Start date

Jan 23, 2022

Status verified date

Oct, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

One intravenous infusion

Interventions

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Primary outcome measure

  • Safety (adverse events) [ Time Frame: Four year follow-up ]

Central Contacts and Locations

Locations

Prodromos Stem Cell Institute

Recruiting

Naples, Florida, United States, 34102

Contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

More Information

Sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Keywords

  • Autism
  • stem cell treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by The Foundation for Orthopaedics and Regenerative Medicine on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.