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CELZ-201 Administration · 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...
CELZ-201 is an investigational therapy being studied for the treatment of recent onset Type 1 Diabetes. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for safety and efficacy in patients with this condition.
CELZ-201 is being developed by Creative Medical Technology Holdings, Inc., a company traded under the ticker symbol CELZ. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Type 1 Diabetes.
CELZ-201 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is recruiting patients with recent onset Type 1 Diabetes to assess the safety and efficacy of the treatment.
CELZ-201 is being studied in a Phase 1 clinical trial with the identifier NCT05626712. This trial is titled 'Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes' and is currently recruiting participants in the United States. The trial is randomized and placebo-controlled, with an enrollment target of 18 patients.
CELZ-201 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CELZ-201, which is intended to expedite the development and review of regenerative medicine therapies for serious conditions.
CELZ-201 is a monoclonal antibody being developed for Type 1 Diabetes. While the specific molecular target is not disclosed, as a monoclonal antibody, it is designed to bind to a specific protein involved in the disease process. The exact mechanism of action is being evaluated in clinical trials.