Lab-grown pancreatic islet cells for diabetes with unaware or severe low blood sugar
Tests CRG-002 islet cells in adults with diabetes and dangerous low blood sugar.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07503028, who can take part
Where in China
- The First Affiliated Hospital of Anhui MedicaluniversityHefei, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celregen Therapeutics
- Trial code
- NCT07503028
- Record updated
- 26 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior islet transplantation; Live-attenuated vaccine received within 2 months prior to enrollment; Type 2 diabetes; Active infection or positive serology for relevant pathogens; Severe cardiovascular disease; Uncontrolled hypertension; Renal impairment or insufficient post-transplant recovery; Significant renal impairment; Recent invasive fungal infection; Active malignancy; History of substance abuse; Severe gastrointestinal/malabsorption disorders; Severe psychiatric disorder; Hematologic disorders affecting HbA1c accuracy; Body mass index (BMI) > 30 kg/m²; Uncontrolled diabetic retinopathy or severe diabetic foot complications; Abnormal liver function; Severe hematologic abnormalities; Coagulopathy; Inadequate contraceptive compliance; Participation in other clinical trials within 6 months; Inability to undergo standard imaging; Other factors deemed unsuitable by investigator.