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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | December 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05018871 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
- Study coordinator: Chadwick Prodromos, MD
- Email: care@thepsci.com
- Phone: 847-699-6810
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
This study tests whether Sensory Integration Therapy helps improve gross motor function more than standard physical therapy in children aged 4–10 with mixed cerebral palsy.
-
Turkish version of ABILHAND-Kids Young CP: translation, adaptation, and reliability
A Turkish version of the ABILHAND-Kids Young CP questionnaire is being created and tested to see if it reliably measures manual ability in 2-to-7-year-olds with cerebral palsy, based on parent reports.
-
Multisite upper limb surgery in children with unilateral cerebral palsy
This study looks at whether individualized multisite upper limb surgery helps improve hand function in kids with hemiplegic cerebral palsy, using each child as their own control before and after surgery.
-
Spinal Stimulation During Walking to See If Spasticity Lessens in Cerebral Palsy
This study tests whether walking with non-invasive spinal stimulation reduces leg muscle tightness and improves walking in children and young adults with cerebral palsy.
-
Combined leg nerve blocks for kids with cerebral palsy after surgery
This study tests whether adding two nerve blocks to standard anesthesia helps control pain in children with cerebral palsy after lower limb surgery.
-
Smartphone gait checks for kids with unilateral spastic CP
This study tests whether a phone’s accelerometer can reliably measure walking in children with unilateral spastic cerebral palsy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.