Treatment for chronic lower back pain using CELZ-201-DDT injections

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

This study is testing if injections of a new treatment called CELZ-201-DDT can help people with chronic lower back pain feel better compared to a placebo.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Creative Medical Technology Holdings Inc (Industry-sponsored)
• Drugs / interventions: Prednisone
• Locations: 1 site (Aventura, Florida)
• Trial ID: NCT06053242 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and effectiveness of CELZ-201-DDT, administered through intramuscular injections, for patients suffering from chronic lower back pain due to degenerative disc disease. It is a double-blinded, randomized, placebo-controlled study that will enroll 30 participants, who will be divided into three dosing cohorts receiving either low, medium, or high doses of the investigational product or a placebo. Each participant will receive six injections into the lumbar musculature under ultrasound guidance, allowing for precise delivery of the treatment. The study aims to provide insights into the potential benefits of this novel therapy compared to standard care options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who have chronic lower back pain and have failed at least two standard therapies.

Not a fit: Patients who have not tried standard therapies or have conditions unrelated to degenerative disc disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients with chronic lower back pain who have not responded to standard therapies.

How similar studies have performed: While this approach is novel, similar studies exploring intramuscular injections for chronic pain have shown promising results.

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 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.

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 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 this trial is running

Aventura, Florida

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

Study contacts

• Study coordinator: Creative Medical Technology

Conditions Chronic Low-back Pain; Degenerative Disc Disease