Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 11 | PHASE3 | Savolitinib, Baxdrostat, Zibotentan/Dapagliflozin, Dapagliflozin, AZD4248 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, Orforglipron, LY3841136, SGLT2 inhibitor |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Zigakibart, OJR520 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 3 | PHASE3 | DCR-PHXC, NNC0519-0130, Semaglutide |
| Amgen Inc. | AMGN | 1 | PHASE3 | Etelcalcetide |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Mezagitamab |
| ProKidney Corp. Class A | PROK | 3 | PHASE3 | Rilparencel |
| Humacyte, Inc. | HUMA | 1 | PHASE3 | Symvess |
| Fresenius Medical Care AG Sponsored ADR | FMS | 6 | PHASE2 | Difelikefalin |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4771261 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | Vonsetamig |
| United Therapeutics Corporation | UTHR | 2 | PHASE1 | 10 GE Xenokidney, GGTA1 KO Thymokidney |
| Pfizer Inc. | PFE | 1 | PHASE1 | PF-07328948 |
| OPKO Health, Inc. | OPK | 1 | PHASE2 | CTAP101 |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB123667 |
CELZ-201-DDT is an investigational small molecule being developed for chronic low-back pain, specifically in patients with degenerative disc disease. It is administered via intramuscular injection. The drug 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 a Phase 1 clinical trial to evaluate the safety, tolerability, and effectiveness of the drug for chronic lower back pain.
CELZ-201-DDT is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is active but not recruiting participants, and the drug has been granted Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA.
CELZ-201-DDT is being studied in one active Phase 1 clinical trial, identified as NCT06053242. This randomized, double-blind, controlled trial is evaluating the safety, tolerability, and effectiveness of intramuscular injections of CELZ-201-DDT for chronic lower back pain associated with degenerative disc disease. The trial is enrolling 45 participants in the United States.
CELZ-201-DDT is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted it Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations, which are intended to expedite development and review, but approval has not been granted.