CREATE-1: CELZ-201 in recent-onset type 1 diabetes
A randomized Phase 1/2a trial testing whether a single intra-arterial infusion of CELZ-201 perinatal tissue-derived cells is safe and potentially beneficial in adults within 180 days of T1D diagnosis. It is recruiting 18 adults at the University of Miami Diabetes Research Institute; no T1D efficacy results are posted yet.
Primary endpoints
- Number of participants with adverse events at 6 months
Results so far
No posted T1D results yet. Public recruitment material describes the trial as safety/feasibility focused and investigational.
The full picture
What is being tested
CREATE-1 asks whether CELZ-201, a perinatal tissue-derived cell product, can be safely delivered to adults soon after T1D diagnosis.12 The intervention is given once by catheter into the dorsal pancreatic artery, then participants are followed for safety labs and mixed-meal testing.2
Design
The trial randomizes 18 adults aged 18-35 in a 2:1 ratio: 12 to CELZ-201 plus standard care and 6 to enhanced standard care alone.2 The primary endpoint is adverse events at 6 months; participants remain in follow-up for about 2 years.12
What to watch
The key signal will be whether C-peptide during mixed-meal tolerance testing is preserved better than standard care, without unacceptable procedural or cell-product safety issues.2 Until then, CELZ-201 should be described as an early investigational immune-modulating cell therapy, not a demonstrated beta-cell regrowth therapy.
References
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Creative Medical Technology Holdings, Inc. Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes. ClinicalTrials.gov NCT05626712. https://clinicaltrials.gov/study/NCT05626712 ↩ ↩2
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Creative Medical Technology Holdings, Inc. CELZ-201 for the Treatment of New Onset Type 1 Diabetes in Adults (CREATE-1 Trial). https://www.creativemedicaltechnology.com/type-1-diabetes-clinical-trial ↩ ↩2 ↩3 ↩4 ↩5