CELZ-201 perinatal tissue-derived cell therapy
Creative Medical Technology Holdings, Inc.
Very early; little to show yet.
What it is
CELZ-201 is described in company materials as 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 control group per trial materials; 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.
Editorial review: .
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 behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: The trial lists safety and mixed-meal-related secondary outcomes in recent-onset T1D per the registry read, but no C-peptide preservation results are posted yet.[1]
- Important harms and treatment burden
- Safety: Company materials describe this as investigational and list catheter, pancreatic-artery infusion, infection, clot, and tumor/cancer risks per the company page (only tumor/cancer wording re-verified verbatim in the extract read); T1D safety data are not yet available.[2]
- Approval and country access
- Recruiting Phase 1/2a (18 planned per company page); no T1D efficacy yetApproval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Registry completion dates imply about 2 years of follow-up, but no durable clinical benefit has been reported in people with T1D.[2]
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.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 20 × 30 + 15 × 20 + 20 × 20 + 20 × 10 + 25 × 20 = 2000; divide by total weight 100. Unrounded weighted result: 20.
The trial lists safety and mixed-meal-related secondary outcomes in recent-onset T1D per the registry read, but no C-peptide preservation results are posted yet.[1]
Registry completion dates imply about 2 years of follow-up, but no durable clinical benefit has been reported in people with T1D.[2]
Company materials describe this as investigational and list catheter, pancreatic-artery infusion, infection, clot, and tumor/cancer risks per the company page (only tumor/cancer wording re-verified verbatim in the extract read); T1D safety data are not yet available.[2]
Narrow first-in-human diabetes population: adults 18-35 treated within 180 days of diagnosis per the company page (registry lists within 1 year) at the Miami site.[3]
Recruiting randomized Phase 1/2a trial with 18 planned participants per company materials; 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 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 per company materials, treated within 180 days of diagnosis per the company page (registry lists within 1 year).23 Per the company page, 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 The trial began in April 2023 and was still recruiting when we re-checked the registry in July 2026; its registry-estimated primary completion date is January 2027, so that is the earliest a first readout could come.1
Why it matters
Unlike stem-cell-derived islet replacement, CELZ-201 is described in company materials as not replacing the missing beta-cell mass directly. The company-stated rationale is that perinatal tissue-derived cells may modulate immune responses and inflammation, potentially preserving residual beta-cell function during the new-onset window, as an untested hypothesis with no human efficacy data posted.2 That frames it as closer to a disease-modifying immunotherapy/regenerative-support concept than a cell-replacement cure as editorial interpretation.
Key caveats
No T1D efficacy results are posted. The intervention also requires catheter-based arterial delivery near the pancreas, and company materials list procedural risks including bleeding, infection, clots, pancreatic injury, and tumor/cancer risk per the company page (only tumor/cancer wording re-verified verbatim in the extract read for this review).2 It should be tracked because it is a live randomized early trial, but the evidence bar is still safety-first.
Coming soon
ETA · Recruiting Phase 1/2a (18 planned per company page); registry-estimated primary completion January 2027. No approval timing yet.
- →First safety readouts (plus HbA1c/insulin/antibody secondaries) from CREATE-1 · Primary completion estimated January 2027
Sources
- [1]Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes · Trial registry · 2026-02-17 — Live-checked 27 August 2026: still recruiting; 18 participants planned; started 7 April 2023; primary completion estimated 31 January 2027. No results posted.
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).
- [2]
- [3]CELZ-201 Clinical Trial · Open-source community
Diabetes Research Institute Foundation. CELZ-201 Clinical Trial.