Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke
NCT ID: NCT05158101
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2022-02-01
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION
NCT05147701
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI
NCT05018832
Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke
NCT07232563
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty
NCT05018767
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD
NCT05018845
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
AlloEx
cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AlloEx
cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chadwick Prodromos, MD
Role: PRINCIPAL_INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Surgical Associates Center
St John's, , Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires, , Argentina
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATG-2-MSC-011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.