Recruiting
Phase 1

Mesenchymal Stem Cells

Sponsor:

The Foundation for Orthopaedics and Regenerative Medicine

Code:

NCT05018871

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Umbilical or placental derived mesenchymal stem cells

Study Details

Brief summary:

This trial will study the safety and efficacy of intravenous infusion of cultured umbilical or placental derived mesenchymal stem cells for the treatment of Cerebral Palsy

Conditions

Cerebral Palsy

Study ID

NCT05018871

Start date

Dec, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of Cerebral Palsy

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

Single intravenous infusion of 100 million cells

Interventions

Umbilical or placental derived mesenchymal stem cells

Umbilical or placental derived mesenchymal stem cells

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chadwick Prodromos, MD

847-699-6810care@thepsci.com

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 16, 2026

Last verified

Oct, 2026

Keywords

  • Cerebral Palsy
  • CP
  • stem cell treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by The Foundation for Orthopaedics and Regenerative Medicine on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.