Clinical trial Recruiting at 2 sites Phase 1 Interventional

Intravenous mesenchymal stem cells for cerebral palsy safety test

Official title: Safety of Cultured Umbilical or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Cerebral Palsy

Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05018871 · Data updated 2026-11-12

This early-stage study tests whether a one-time IV infusion of cultured umbilical/placental stem cells is safe and can help people with cerebral palsy.

More Cerebral Palsy trials

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
StartedDecember 2026
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedOctober 16, 2026
Trial IDNCT05018871 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with cerebral palsy who meet the inclusion criteria and do not have active infection, cancer, multisystem organ failure, pregnancy, or other listed contraindications.

Probably not a fit

Participants with active infections, active cancer, significant organ failure, pregnancy, or other contraindications may not benefit or may be at risk.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety of a single intravenous infusion of cultured mesenchymal stem cells derived from umbilical cord or placental tissue in individuals with cerebral palsy. Participants receive one infusion and are monitored for adverse events and preliminary signals of benefit. The study is investigator-initiated with sponsor support from the Foundation for Orthopaedics and Regenerative Medicine and is conducted at Prodromos Stem Cell Institute locations in Naples, Florida and Athens. The goal is to establish safety for future trials and explore any early evidence of clinical impact.

Why it matters

Potential benefit: If safe and potentially beneficial, the treatment could lead to larger studies exploring longer-term effects on CP symptoms.

How similar studies have gone: Prior studies suggest stem cell approaches can be safe in CP; this is an early-stage, exploratory trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Prodromos Stem Cell Institute
    Naples, Florida, United States
    Recruiting
  • Prodromos Stem Cell Institute
    Athens, Greece
    Recruiting

Study contacts

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.