Safety, Tolerability, and Effectiveness of Intramuscular... | NCT06053242

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose	Experimental	Subjects in the low dose arm will receive a single administration of either 6x10^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.	Drug: CELZ-201-DDT Other: Placebo
Medium Dose	Experimental	Subjects in the medium dose arm will receive a single administration of either 30x10^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.	Drug: CELZ-201-DDT Other: Placebo
High Dose	Experimental	Subjects in the high dose arm will receive a single administration of either 60x10^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.	Drug: CELZ-201-DDT Other: Placebo
Expanded High Dose	Experimental	Subjects in the expanded high dose arm will receive a single administration of either 120x10^6 cells (n=10) or a placebo injection (n=5). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CELZ-201-DDT	Drug	Subjects 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 months

Secondary Outcomes

Measure	Description	Time Frame
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.	12 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.

Eligibility Module

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.

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases