NCT07503028|Enrolling By InvitationEarly Phase 1
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Sponsor study identifier
interventional
10
1 country
1
Study Start
October 17, 2025
Actual (reported)Primary Completion
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is an open-label, single-arm, non-randomized trial designed to evaluate the safety and preliminary efficacy of CRG-002 administered via portal vein infusion or transplantation beneath the anterior rectus sheath in patients with type 1 diabetes mellitus (T1DM) or pancreatogenic diabetes who have hypoglycemia unawareness or severe hypoglycemic events.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2025
Actual (reported)February 23, 2026
Actual (reported)March 31, 2026
Actual (reported)January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
Number of adverse events as assessed by CTCAE v6.0，including Adverse Events of Special Interest (AESI), Treatment-Related Adverse Events (TEAE), Treatment-Related Adverse Events (TRAE), and Procedure-Related Adverse Events (PRAE); Serious Adverse Events (SAE), Treatment-Related Serious Adverse Events (TRSAE), and Procedure-Related Serious Adverse Events (PRAE)
Within one year after CRG-002 transplantation
Daily insulin dosage of subjects
Within one year after CRG-002 transplantation
Time to subjects achieving insulin independence.
Within one year after CRG-002 transplantation
Numbers of subjects achieving insulin independence.
Within one year after CRG-002 transplantation
Changes in blood glucose levels
Within one year after CRG-002 transplantation
Changes in Time in range of glucose
Within one year after CRG-002 transplantation
Time to achieving stimulated C-peptide level ≥0.3 ng/mL
Within one year after CRG-002 transplantation
Number of subjects achieving stimulated C-peptide level ≥0.3 ng/mL
Within one year after CRG-002 transplantation
Number of subjects experiencing hypoglycemia unawareness or severe hypoglycemic events
Within one year after CRG-002 transplantation
CRG002
Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The First Affiliated Hospital of Anhui Medicaluniversity
Hefei, Anhui, 230022, China
Chen S, Du K, Zou C. Current progress in stem cell therapy for type 1 diabetes mellitus. Stem Cell Res Ther. 2020 Jul 8;11(1):275. doi: 10.1186/s13287-020-01793-6.
Gregory GA, Robinson TIG, Linklater SE, Wang F, Colagiuri S, de Beaufort C, Donaghue KC; International Diabetes Federation Diabetes Atlas Type 1 Diabetes in Adults Special Interest Group; Magliano DJ, Maniam J, Orchard TJ, Rai P, Ogle GD. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. Lancet Diabetes Endocrinol. 2022 Oct;10(10):741-760. doi: 10.1016/S2213-8587(22)00218-2. Epub 2022 Sep 13.
First Submitted
February 23, 2026
First Posted
March 31, 2026
Study Start
October 17, 2025
Actual (reported)Primary Completion
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus
Contact the study team to confirm eligibility.
Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, Ludwig B, Norgaard K, Pettus J, Renard E, Skyler JS, Snoek FJ, Weinstock RS, Peters AL. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021 Dec;64(12):2609-2652. doi: 10.1007/s00125-021-05568-3.
Study Completion
January 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2025-09
Confidential Information
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Source: ClinicalTrials.gov.
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