Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06053242 | Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain | PHASE1 | RECRUITING | 45 | — | — | May 21, 2024 | May 1, 2027 | Feb 13, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | OTHER | Subjects 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. |
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 st...