The Foundation for Orthopaedics and Regenerative Medicine
This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of Stroke
This patient funded trial aims to study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell (MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of 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…
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
cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes
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