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Enrolling by invitation 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

Early Phase I Interventional T1DM - Type 1 Diabetes Mellitus Pancreatogenic Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CRG002.
Who it may be relevant to
Registry conditions: T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug CRG002
    Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

Primary outcome measures

  • Safety as assessed by number of adverse events accoridng to CTCAE v 6.0 [Time frame: Within one year after CRG-002 transplantation]
Secondary outcome measures (7)
  • Daily insulin dosage of subjects [Time frame: Within one year after CRG-002 transplantation]
  • Time to subjects achieving insulin independence. [Time frame: Within one year after CRG-002 transplantation]
  • Numbers of subjects achieving insulin independence. [Time frame: Within one year after CRG-002 transplantation]
  • Changes in blood glucose levels [Time frame: Within one year after CRG-002 transplantation]
  • Changes in Time in range of glucose [Time frame: Within one year after CRG-002 transplantation]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Anhui Medicaluniversity — Hefei

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. PMID 32641151
  • 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):74 PMID 36113507
  • 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

Identifiers

NCT: NCT07503028 · CRG002SEIIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗