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

NCT07503028 | Enrolling By Invitation Early Phase 1

• 1 other identifier: CRG002SEIIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T1DM - Type 1 Diabetes Mellitus; Pancreatogenic Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Other Outcomes (4)

• 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

Study Arms (1)

Experimental group

EXPERIMENTAL

CRG002

Drug: CRG002

Interventions

CRG002 DRUG

Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 2 diabetes.
• Body mass index (BMI) \> 30 kg/m².
• Uncontrolled diabetic retinopathy or severe diabetic foot complications.
• Active infection or positive serology for relevant pathogens.
• Severe cardiovascular disease.
• Uncontrolled hypertension.
• Hematologic disorders affecting HbA1c accuracy.
• Abnormal liver function.
• Prior islet transplantation.
• Renal impairment or insufficient post-transplant recovery.
• Significant renal impairment.
• Recent invasive fungal infection.
• Severe hematologic abnormalities.
• Coagulopathy.
• Inadequate contraceptive compliance.

Sponsors & Collaborators

• Celregen Therapeutics: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medicaluniversity

Hefei, Anhui, 230022, China

Location

Related Publications (3)

• 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.

  PMID: 32641151 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.

  PMID: 36113507 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.

  PMID: 34590174 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 31, 2026
• Study Start: October 17, 2025
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): January 18, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)