The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.
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.
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.