CELZ-201 perinatal tissue-derived cell therapy
Creative Medical Technology Holdings, Inc.
Very early; little to show yet.
CELZ-201 is a single-dose perinatal tissue-derived cell therapy being tested in adults with very recent-onset T1D. The CREATE-1 Phase 1/2a trial delivers CELZ-201 by intra-arterial infusion into the dorsal pancreatic artery, with a randomized standard-care control group; there are no posted T1D efficacy results yet, so this is an early beta-cell-preservation/immune-modulation candidate rather than a demonstrated regenerative cure.
The scorecard
The trial is designed to measure safety and efficacy in recent-onset T1D, including mixed-meal testing, but no C-peptide preservation results are posted yet.[1]
Participants are followed for about 2 years, but no durable clinical benefit has been reported in people with T1D.[2]
Public materials describe this as investigational and list catheter, pancreatic-artery infusion, infection, clot, and tumor/cancer risks; T1D safety data are not yet available.[2]
Narrow first-in-human diabetes population: adults 18-35 treated within 180 days of diagnosis at a single Miami site.[3]
Recruiting randomized Phase 1/2a trial with 18 planned participants; still early and not approved.[1]
The full picture
What it is
CELZ-201 is an investigational perinatal tissue-derived cell product being tested for adults with newly diagnosed type 1 diabetes.12 Public trial materials describe cells from a single human donor tissue source collected around delivery, prepared from a master cell bank, and given once through an intra-arterial infusion into the dorsal pancreatic artery.2
Study design
CREATE-1 (NCT05626712) is a randomized, controlled Phase 1/2a study at the Diabetes Research Institute, University of Miami.13 It plans 18 adults aged 18-35 with recent-onset T1D, treated within 180 days of diagnosis.23 Twelve participants receive CELZ-201 plus standard care and six receive enhanced standard care only.2 The primary endpoint is adverse events at 6 months.1
Why it matters
Unlike stem-cell-derived islet replacement, CELZ-201 is not replacing the missing beta-cell mass directly. The rationale is that perinatal tissue-derived cells may modulate immune responses and inflammation, potentially preserving residual beta-cell function during the new-onset window.2 That makes it closer to a disease-modifying immunotherapy/regenerative-support concept than a cell-replacement cure.
Key caveats
No T1D efficacy results are posted. The intervention also requires catheter-based arterial delivery near the pancreas, and public materials list procedural risks including bleeding, infection, clots, pancreatic injury, blood-glucose variation, allergic reaction, and tumor/cancer risk.2 It should be tracked because it is a live randomized early trial, but the evidence bar is still safety-first.
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 (last updated 2026). https://clinicaltrials.gov/study/NCT05626712 ↩ ↩2 ↩3
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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 ↩6
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Diabetes Research Institute Foundation. CELZ-201 Clinical Trial. https://diabetesresearch.org/celz-201-clinical-trial/ ↩ ↩2
Coming soon
ETA · Recruiting Phase 1/2a; study completion estimated 2028, with no approval timing yet
- →First safety and mixed-meal C-peptide readouts from CREATE-1 · Study follow-up runs through 2028
Sources
- [1]Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes · registry · 2026-02-17
- [2]CELZ-201 for the Treatment of New Onset Type 1 Diabetes in Adults · manufacturer
- [3]CELZ-201 Clinical Trial · manufacturer