Using stem cell exosomes to treat Parkinson's Disease
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
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 |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 1 site (St John's) |
| Trial ID | NCT05152394 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Parkinson's Disease who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other significant health issues may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
St John's
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.