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Enrolling by Invitation

NCT Number: NCT07503028

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.

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Key information

Conditions

T1DM - Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatogenic Diabetes Mellitus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The First Affiliated Hospital of Anhui Medicaluniversity

Hefei, Anhui, 230022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Active malignancy.
  • History of substance abuse.
  • Severe gastrointestinal/malabsorption disorders.
  • Severe psychiatric disorder.
  • Participation in other clinical trials within 6 months.
  • Live-attenuated vaccine received within 2 months prior to enrollment.
  • Inability to undergo standard imaging.
  • Other factors deemed unsuitable by investigator.

Treatment and study plan

CRG002

Drug

Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

Primary outcomes

  1. Safety as assessed by number of adverse events accoridng to CTCAE v 6.0

    Time frame: Within one year after CRG-002 transplantation

    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)

Secondary outcomes

  1. Daily insulin dosage of subjects

    Time frame: Within one year after CRG-002 transplantation

  2. Time to subjects achieving insulin independence.

    Time frame: Within one year after CRG-002 transplantation

  3. Numbers of subjects achieving insulin independence.

    Time frame: Within one year after CRG-002 transplantation

  4. Changes in blood glucose levels

    Time frame: Within one year after CRG-002 transplantation

    Changes in blood glucose levels in subjects after CRG-002 transplantation

  5. Changes in Time in range of glucose

    Time frame: Within one year after CRG-002 transplantation

  6. Time to achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or a ≥1% reduction from baseline.

    Time frame: Within one year after CRG-002 transplantation

  7. Number of subjects achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or ≥1% HbA1c reduction from baseline (if baseline HbA1c <7.0%).

    Time frame: Within one year after CRG-002 transplantation

Other outcomes

  1. Time to achieving stimulated C-peptide level ≥0.3 ng/mL

    Time frame: Within one year after CRG-002 transplantation

  2. Number of subjects achieving stimulated C-peptide level ≥0.3 ng/mL

    Time frame: Within one year after CRG-002 transplantation

  3. Number of subjects experiencing hypoglycemia unawareness or severe hypoglycemic events

    Time frame: Within one year after CRG-002 transplantation

  4. Changes in islet cell autoantibody markers

    Time frame: Within one year after CRG-002 transplantation

    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)

Sponsors and collaborators

Lead sponsor

Celregen Therapeutics

Industry

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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