Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CELZ-201 Administration
CELZ-201 · 1 trial · 2 indications
The primary outcome to be assessed is tolerability and safety of the CELZ-201 therapy. The incidence of adverse events (grade 2 or above as per CTCAE version 5.0) in both groups at 6 months.
| Arm | Type | Description |
|---|---|---|
| CELZ-201 Treatment Group | EXPERIMENTAL | Participants in this group will receive a single dose of CELZ-201, in addition to standard of care of care for Type 1 Diabetes treatment. |
| Control Group | PLACEBO_COMPARATOR | Participants in this group will receive standard of care for Type 1 Diabetes only. |
| Name | Type | Description |
|---|---|---|
| CELZ-201 Administration | BIOLOGICAL | Participants in this group will receive a single dose of CELZ-201, in addition to standard of care for Type 1 Diabetes treatment. Perinatal tissue derived cells will be administered at a dose of 1x10\^6 cells/kg via an intra-arterial infusion into the dorsal pancreatic artery. |
| Control Group | OTHER | Enhanced standard of care for Type 1 Diabetes treatment only. |
Inclusion Criteria: 1. Subject must be able to understand and provide signed informed consent. 2. Males and females, 18-35 years of age. 3. Diagnosis of T1D within 1 year, with stimulated C-peptide peak level \>0.6 ng/mL as assessed by 4-hour MMTT at the time of Visit 0 (screening). 4. Diagnosed wi...
Top 10 of 19 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 6 | PHASE3 | Tirzepatide, Baricitinib, LY4057996, Insulin Lispro |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Insulin icodec, Insulin aspart, NNC0194-0499, Semaglutide, NNC0497-0040 |
| Sanofi SA Sponsored ADR | SNY | 12 | PHASE3 | teplizumab/mL, Brivekimig, Frexalimab, Insulin |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | VX-880, VX-017, VX-264 |
| vTv Therapeutics, Inc. Class A | VTVT | 2 | PHASE3 | Cadisegliatin |
| SAB Biotherapeutics, Inc. | SABS | 1 | PHASE2 | SAB-142 |
| MannKind Corporation | MNKD | 2 | PHASE2 | Technosphere Insulin |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201 |
| Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 Sh | IMCR | 1 | PHASE1 | IMC-S118AI |
| Sana Biotechnology, Inc. | SANA | 1 | EARLY_PHASE1 | UP421 |
CELZ-201 is being developed for the treatment of Type 1 Diabetes, also called diabetes mellitus type 1. It is intended for patients with recent onset disease. The program is in Phase 1 clinical development and is not approved for commercial use.
CELZ-201 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 asset in Type 1 Diabetes.
CELZ-201 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. One Phase 1 trial is currently active and recruiting participants, and no trials for CELZ-201 have been completed.
CELZ-201 is being studied in the Phase 1 trial NCT05626712, titled Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes. The trial is recruiting in the United States, has a planned enrollment of 18 participants, and is placebo controlled.
Yes. CELZ-201 Administration is another name used for CELZ-201, so searches for either term refer to the same investigational product being developed by Creative Medical Technology Holdings for Type 1 Diabetes.
The Phase 1 trial NCT05626712 enrolls adults 18 years of age and older of any sex who have recent onset Type 1 Diabetes. Healthy volunteers are not eligible. The study is randomized, placebo controlled, and does not use double blinding.