Status:
RECRUITING
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Lead Sponsor:
Creative Medical Technology Holdings Inc
Conditions:
Chronic Low-back Pain
Degenerative Disc Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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.
Detailed Description
This study is a double-blinded, randomized, placebo-controlled, dose escalation Phase 1/2a study. The objective is to determine the safety, tolerability, and efficacy of CELZ-201-DDT administered as a...
Eligibility Criteria
Inclusion
- 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
- 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 Schedule I or II controlled substances.
- Body Mass Index (BMI) \> 40 kg/m2.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06053242
Start Date
May 21 2024
End Date
October 1 2026
Last Update
August 28 2025
Active Locations (1)
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1
Spine and Wellness Centers of America
Aventura, Florida, United States, 33180