The Foundation for Orthopaedics and Regenerative Medicine
This trial will study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical-cord or placental derived mesenchymal stem cells for the treatment of spinal cord injury
Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured allogeneic adult umbilical-cord or placental derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-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.
Inclusion Criteria: * Diagnosis of Spinal Cord Injury * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Anticoagulation medicine use * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Previous organ transplant * Hypersensitivity to sulfur * Continued drug abuse * Pre-menopausal women not using contraception
Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal injection
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