Clinical trial Recruiting at 2 sites Phase 1 Interventional

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

PhasePhase 1
Study typeInterventional
SexAll
Enrollment15 (estimated)
SponsorThe Foundation for Orthopaedics and Regenerative Medicine
Academic / other
Locations2 sites (Naples, Florida and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2022
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedOctober 20, 2026
Trial IDNCT05158101 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.