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.
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.
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.
Parallel
CELZ-201-DDT
DrugSubjects enrolled in the trial will receive CELZ-201-DDT at the specified dose into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.
Placebo
Other interventionSubjects will receive a placbeo injection into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.
Evaluate safety of CELZ-201-DDT administered as intramuscular injections in subjects experiencing chronic lower back pain at a low, medium, or high dose.
The primary outcome will be evaluated by the incidence of grade 3 or 4 or serious adverse events in all dosing cohorts at 6 months.
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
The secondary outcome will be evaluated by change in pain as judged by the Visual Analogue Score (VAS), using a score of 0-10.
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
The secondary outcome will be evaluated by change in disability as judged by the Oswestry Disability Index (ODI) for back pain.
Evaluate the potential efficacy of CELZ-201-DDT therapy in terms of pain alleviation and improved mobility in subjects experiencing chronic low back pain.
The secondary outcome will be evaluated by change in requirements for pain medications to manage back pain.
Click on the lead sponsor to view all of their trials.
