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

• Status: Not yet recruiting
• Trial end date: 2026-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creative Medical Technology Holdings Inc

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 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.