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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | CRG002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRG002 | Drug | Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medicaluniversity | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32641151 | Background | 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. | |
| 36113507 | Background | 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. |
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Confidential Information
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| Numbers of subjects achieving insulin independence. |
| Within one year after CRG-002 transplantation |
| Changes in blood glucose levels | Changes in blood glucose levels in subjects after CRG-002 transplantation | Within one year after CRG-002 transplantation |
| Changes in Time in range of glucose | Within one year after CRG-002 transplantation |
| Time to achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or a ≥1% reduction from baseline. | Within one year after CRG-002 transplantation |
| Number of subjects achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or ≥1% HbA1c reduction from baseline (if baseline HbA1c <7.0%). | Within one year after CRG-002 transplantation |
| Number of subjects experiencing hypoglycemia unawareness or severe hypoglycemic events | Within one year after CRG-002 transplantation |
| Changes in islet cell autoantibody markers | Changes in islet cell autoantibody markers(GADA) from baseline in subjects with type 1 diabetes mellitus, including glutamate decarboxylase autoantibody (GADA), insulin autoantibody (IAA), protein tyrosine phosphatase antibody (IA-2A), and zinc transporter 8 antibody (ZnT8) | Within one year after CRG-002 transplantation |
| 34590174 | Background | 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. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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