CREATE-1: CELZ-201 in recent-onset type 1 diabetes
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-02-19.
Most recent recorded citation date: 2026-02-17. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18-35 with recent-onset type 1 diabetes, treated within 180 days of diagnosis, otherwise healthy enough for the protocol. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No T1D results are posted to the registry. The company recruitment page describes the trial as safety/feasibility focused and investigational.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Primary endpoints
- Number of participants with adverse events at 6 months
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
According to the company recruitment page, 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 The registry's primary endpoint is adverse events at 6 months, with C-peptide during a 4-hour MMTT as a secondary outcome.1 Until then, CELZ-201 should be described as an early investigational immune-modulating cell therapy, not a demonstrated beta-cell regrowth therapy.
Sources
- [1]Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes · Trial registry · 2026-02-17
Creative Medical Technology Holdings, Inc. Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes. ClinicalTrials.gov NCT05626712.
- [2]