An Exploratory Clinical Study Evaluating Allogeneic iPSC-derived Pancreatic Islet Cells (CRG-002) for the Treatment of Diabetic Patients With Hypoglycemia Unawareness or Severe Hypoglycemic Events

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancreatogenic Diabetes Mellitus; T1DM - Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: CRG002

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medicaluniversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-70 years, any gender.
2. Long-standing type 1 diabetes or pancreatic diabetes.
3. Significant pancreatic islet dysfunction.
4. Hemoglobin A1c within clinically acceptable range.
5. At least 1 hypoglycemic event requiring external intervention within 12 months.
6. Able to comply with intensive glucose management.
7. Agree to use the study-designated monitoring device.
8. Psychologically stable.
9. Full legal capacity.

Exclusion Criteria:

1. Type 2 diabetes.
2. Body mass index (BMI) > 30 kg/m².
3. Uncontrolled diabetic retinopathy or severe diabetic foot complications.
4. Active infection or positive serology for relevant pathogens.
5. Severe cardiovascular disease.
6. Uncontrolled hypertension.
7. Hematologic disorders affecting HbA1c accuracy.
8. Abnormal liver function.
9. Prior islet transplantation.
10. Renal impairment or insufficient post-transplant recovery.
11. Significant renal impairment.
12. Recent invasive fungal infection.
13. Severe hematologic abnormalities.
14. Coagulopathy.
15. Inadequate contraceptive compliance.
16. Active malignancy.
17. History of substance abuse.
18. Severe gastrointestinal/malabsorption disorders.
19. Severe psychiatric disorder.
20. Participation in other clinical trials within 6 months.
21. Live-attenuated vaccine received within 2 months prior to enrollment.
22. Inability to undergo standard imaging.
23. Other factors deemed unsuitable by investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; CRG002	Drug: CRG002; Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Celregen Therapeutics

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Diabetologia. 2022 Jan;65(1):255. doi: 10.1007/s00125-021-05600-6.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2025
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): January 18, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CRG002SEIIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidential Information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No