Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
This study tests a new injectable treatment called CELZ-201-DDT that is injected into muscles along the spine to help relieve chronic lower back pain. Researchers will monitor how safe the treatment is, how well it is tolerated by the body, and whether it effectively reduces pain.
Key Objective: This trial is testing whether CELZ-201-DDT can safely reduce chronic lower back pain through direct injection into the paraspinal muscles.
Who to Consider: People with chronic lower back pain who have not found adequate relief with other treatments and are willing to try an investigational injectable therapy should consider enrolling.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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