NCT07503028Enrolling by invitationEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 23 Feb 2026
- Start date
- 17 Oct 2025
- Primary completion date
- 18 Jan 2028
- Lead sponsor
- Celregen Therapeutics
- Diseases
- Type 1 diabetes
- NCT number
- NCT07503028
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 17 Oct 2025 to the primary completion date, 18 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior islet transplantation.
- Live-attenuated vaccine received within 2 months prior to enrollment.
Other illness
- 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.
Lab values
- Hematologic disorders affecting HbA1c accuracy.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medicaluniversity Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.