A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease

CELZ-201-ADAPT

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.

2024-05-21

2025-05-21

2026-05-21

Recruiting

Early phase I

30

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. 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 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.

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2024-05-31