Using stem cell exosomes to treat Parkinson's Disease
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05152394 · Data updated 2026-11-12
This study is testing if a new treatment using stem cell exosomes given through the nose can help people with Parkinson's Disease feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 17, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05152394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with Parkinson's Disease who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancers, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety and efficacy of intranasal administration of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for patients with Parkinson's Disease. Participants will receive two doses of exosomes, with evaluations scheduled at multiple time points over four years to assess treatment outcomes. The study aims to provide insights into the potential therapeutic benefits of this innovative approach for managing Parkinson's Disease.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for managing symptoms of Parkinson's Disease.
How similar studies have gone: While the use of stem cell-derived exosomes is a relatively novel approach, preliminary studies in related areas have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's Disease * Understanding and willingness to sign a written informed consent document 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. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur * Anticoagulation medicine use
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
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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.