Using stem cell exosomes through the nose to treat stroke
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for the Treatment of Stroke
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05158101 · Data updated 2026-11-12
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 |
| 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 | February 1, 2022 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05158101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with stroke who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancer, or other serious medical conditions 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 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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
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AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
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Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
-
Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
-
Dual-task balance training plus computer-based cognitive training after stroke
In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.
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.