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CELZ-201-DDT · 1 trial · 2 indications
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...
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CELZ-201-DDT is an investigational small molecule being developed for the treatment of chronic low-back pain, specifically in patients with degenerative disc disease. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CELZ-201-DDT is being developed by Creative Medical Technology Holdings, Inc., a company traded under the ticker symbol CELZ. The company is conducting clinical trials for this investigational drug in the United States.
CELZ-201-DDT is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite its development and review process.
CELZ-201-DDT is being studied in a Phase 1 clinical trial with the identifier NCT06053242. This trial is recruiting participants in the United States and is evaluating the safety, tolerability, and effectiveness of intramuscular injections of CELZ-201-DDT for chronic lower back pain.
CELZ-201-DDT is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential to treat chronic low-back pain associated with degenerative disc disease.