Using stem cell exosomes through the nose to treat stroke
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for the Treatment of Stroke
This study is testing if giving stem cell exosomes through the nose can help people who have had a stroke recover better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05158101 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for treating stroke. Patients diagnosed with stroke will receive two doses of exosomes administered through their nasal cavities over consecutive days. The study will evaluate participants' safety and efficacy outcomes at multiple time points, including one month before treatment and at 1, 6, 12, 24, 36, and 48 months post-treatment. For patients with more severe conditions, an additional treatment using their own activated lymphocytes will be provided.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with stroke who are willing to provide informed consent.
Not a fit: Patients with active infections, cancer, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel and non-invasive treatment option for stroke patients.
How similar studies have performed: While the use of stem cell exosomes is a growing area of interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Stroke * 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
Where this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Center for Investigation in Tissue Engineering and Cellular Therapy — Buenos Aires, Argentina (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.