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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase: Enrolling; Phase 1

Conditions: Stroke

Treatments: Biological: AlloEx

Study type: Interventional

Funder types: Other

Identifiers

NCT05158101

ATG-2-MSC-011

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Treatment Group (AlloEx)

Experimental group

Description:

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.

Treatment:

Biological: AlloEx