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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
CELZ-201-DDT is an investigational small molecule developed by Creative Medical Technology Holdings, Inc. for chronic low-back pain. It is being studied as an intramuscular injection and has received FDA Fast Track designation. The program is in Phase 1 clinical development.
CELZ-201-DDT is being developed for the treatment of chronic low-back pain, including patients with degenerative disc disease. It is not yet approved for any use and remains an investigational therapy in clinical development.
CELZ-201-DDT is being developed by Creative Medical Technology Holdings, Inc., which trades under the ticker CELZ. The company is the sponsor of the clinical program evaluating the drug for chronic low-back pain.
CELZ-201-DDT is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program has received FDA Fast Track designation for its development in chronic low-back pain.
CELZ-201-DDT is being evaluated in one clinical trial, NCT06053242, titled Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain. The Phase 1 study is active but not recruiting, has enrolled 45 participants, and is conducted in the United States.
The Phase 1 trial NCT06053242 is a randomized, double-blind, controlled study of intramuscular CELZ-201-DDT in adults with chronic low-back pain and degenerative disc disease. It enrolled 45 participants aged 18 years and older in the United States and is active but not recruiting.