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...