Actively Recruiting
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Led by Creative Medical Technology Holdings Inc · Updated on 2026-02-13
45
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Aged between 18 and 80 years, any gender or race
- Have failed at least two standard treatments for lower back pain (exercise/physical therapy; oral analgesics including NSAIDs and acetaminophen; skeletal muscle relaxants) after trying each for at least 3 months
- Failed these standard treatments within 12 months before enrolling
- Have proof of lower back pain shown by MRI with disc degeneration, Oswestry Disability Index score between 21-80%, or pain score over 5 out of 10
- Female participants must not be breastfeeding, must not intend to become pregnant during the study, and must use contraceptives
- Male participants must agree to use contraceptives and not donate sperm during the study
- May be on stable opioids, narcotics, or muscle relaxants for at least 30 days before screening
You will not qualify if you...
- History of cancer in the last five years
- Spinal infections or tumors
- Kidney failure requiring dialysis or poor kidney function (eGFR less than 60)
- Liver tests (ALT, AST) more than twice normal or high bilirubin
- Positive pregnancy test
- History of blood cell diseases
- Uncontrolled diabetes with hemoglobin A1c over 8%
- Uncontrolled high blood pressure (systolic >140 or diastolic >90) unless properly treated
- Any active infection including at injection sites
- On chronic immunosuppressive transplant therapy (less than 5 mg prednisone daily allowed)
- Life expectancy under 2 years due to serious illness
- Smoked or used substances in the past six weeks
- Heavy alcohol use (over 14 drinks per week for men or 7 for women)
- Participated in other investigational drug or device studies within 30 days
- Previously received gene therapy
- Using strong opioids over 90 mg/day average in the past week
- Body Mass Index over 40 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Spine and Wellness Centers of America
Aventura, Florida, United States, 33180
Actively Recruiting
Research Team
C
Creative Medical Technology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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