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NCT05158101 Clinical Trial

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Stroke

Stroke Clinical Trial

Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Stroke

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05158101
Other study ID # ATG-2-MSC-011
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 1, 2022
Est. completion date February 2026

Study information
Verified date November 2021
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Stroke

Description:

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Stroke. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations
Country Name City State
Antigua and Barbuda Medical Surgical Associates Center St. John's
Argentina Center for Investigation in Tissue Engineering and Cellular Therapy Buenos Aires
Mexico Medyca Bosques San Pedro Garza García N.L

Sponsors (1)
Lead Sponsor Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Countries where clinical trial is conducted

Antigua and Barbuda,  Argentina,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (adverse events) Clinical monitoring of possible adverse events or complications Four year follow-up
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