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

Last updated: April 15, 2025
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Cerebral Ischemia

Stroke

Treatment

AlloEx

Clinical Study ID

NCT05158101
ATG-2-MSC-011
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Stroke

  • Understanding and willingness to sign a written informed consent document

Exclusion

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) compromisepatient's safety.

  • Continued drug abuse

  • Pre-menopausal women not using contraception

  • Previous organ transplant

  • Hypersensitivity to sulfur

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: AlloEx
Phase: 1
Study Start date:
February 01, 2022
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Medical Surgical Associates Center

    St. John's,
    Antigua and Barbuda

    Active - Recruiting

  • Center for Investigation in Tissue Engineering and Cellular Therapy

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Medyca Bosques

    San Pedro Garza García, N.L
    Mexico

    Site Not Available

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