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 dialysis or an eGFR of less than 60 mL/min/1.73m2. * ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range. * Positive pregnancy test. * History of blood cell diseases. * Uncontrolled diabetes mellitus - HgA1c \>8%. * Uncontrolled hypertension defined as a systolic blood pressure of \>140 mmHg or diastolic blood pressure of \>90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll. * Patients known to have any active infection, including infection of the injection site(s), and/or any active systemic or local infection. * Patients on chronic immunosuppressive transplant therapy. Patients receiving \<5 mg of Prednisone daily may be included. * Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years. * Recent smoking history or substance abuse (within six weeks). * Heavy alcohol use (greater than 14 drinks per …