Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

Inclusion Criteria: * Ability of participant to understand and the willingness to sign a written informed consent document. * Between 18-80 years of age and may be of either gender or any race. * Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise/physical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined. * Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial. * Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of \>5 on a scale of 0-10. * Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices. * Any male subject must agree to use contraceptives and not donate sperm during the study. * Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening. Exclusion Criteria: * History of cancer in the last five years. * Spinal infections and spinal tumors. * Renal insufficiency requiring…