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

Eligibility 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.
• * 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 week for men or 7 drinks per week for women per NIAAA)
• * Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment.
• * Any patient who has received gene therapy in the past.
• * Subjects who are currently on opioid medication(s).
• * Body Mass Index (BMI) \> 40 kg/m2.