NCT05158101

Brief 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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for phase_1 stroke

Timeline
Completed

Started Feb 2022

Longer than P75 for phase_1 stroke

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

December 2, 2021

Last Update Submit

April 15, 2025

Conditions

Stroke

Keywords

Strokestem cell treatment

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Study Arms (1)

Treatment Group (AlloEx)

EXPERIMENTAL

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

AlloExBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

Treatment Group (AlloEx)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Center for Investigation in Tissue Engineering and Cellular Therapy

Buenos Aires, Argentina

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chadwick Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

February 1, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)AR(1)