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RecruitingNCT05158101Updated Apr 17, 2025

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke

A Phase 1 interventional study of AlloEx in Stroke, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Sex
All
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Study summary

This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Stroke

Read the detailed description

This patient funded trial aims to study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of UC-MSC exosomes. The total dose will be 4 CC of AlloEx, approximately 800 billion exosomes, for each day. Patients will receive instillations on back-to-back days totaling 2 doses. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • stem cell treatment
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of Stroke
  • Understanding and willingness to sign a written informed consent document

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Treatment Group (AlloEx)

    Intranasal instillations of 4 CCs of AlloEx between both nasal cavaties, which is approximately 800 billion exosomes in total. Second dose of 4 CCs to be receive the following day.

    Biological: AlloEx

Interventions

  • BiologicalAlloEx

    cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

06

What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Time frame: Four year follow-up

07

Study locations

2 of 2 sites recruiting
  • Medical Surgical Associates Center
    St. John's, Antigua and Barbuda
    Recruiting
  • Center for Investigation in Tissue Engineering and Cellular Therapy
    Buenos Aires, Argentina
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05158101
Lead sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Responsible party
Sponsor
First posted
Dec 15, 2021
Start date
Feb 1, 2022
Primary completion
Feb 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Apr 17, 2025

Study contacts

Chadwick Prodromos, MD
principal investigator · The Foundation for Orthopaedics and Regenerative Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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