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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Low-back Pain, Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT06053242

Run by

Creative Medical Technology Holdings Inc

People needed

45

Starts

2024-05-21

Expected to finish

2027-05-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.

You may not qualify if…

• 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 with an average baseline MED >90 mg/day during the screening period are excluded. The average will be calculated over a 7-day time period.
• Body Mass Index (BMI) > 40 kg/m2.

Where it is running

• Spine and Wellness Centers of America — Aventura, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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