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

August 24, 2026 updated by: Celregen Therapeutics
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medicaluniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Type 2 diabetes.
  2. Body mass index (BMI) > 30 kg/m².
  3. Uncontrolled diabetic retinopathy or severe diabetic foot complications.
  4. Active infection or positive serology for relevant pathogens.
  5. Severe cardiovascular disease.
  6. Uncontrolled hypertension.
  7. Hematologic disorders affecting HbA1c accuracy.
  8. Abnormal liver function.
  9. Prior islet transplantation.
  10. Renal impairment or insufficient post-transplant recovery.
  11. Significant renal impairment.
  12. Recent invasive fungal infection.
  13. Severe hematologic abnormalities.
  14. Coagulopathy.
  15. Inadequate contraceptive compliance.
  16. Active malignancy.
  17. History of substance abuse.
  18. Severe gastrointestinal/malabsorption disorders.
  19. Severe psychiatric disorder.
  20. Participation in other clinical trials within 6 months.
  21. Live-attenuated vaccine received within 2 months prior to enrollment.
  22. Inability to undergo standard imaging.
  23. Other factors deemed unsuitable by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
CRG002
Drug: CRG002
Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Within one year after CRG-002 transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily insulin dosage of subjects
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
Time to subjects achieving insulin independence.
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
Numbers of subjects achieving insulin independence.
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
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
Within one year after CRG-002 transplantation
Changes in Time in range of glucose
Time Frame: Within one year after CRG-002 transplantation
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
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
Within one year after CRG-002 transplantation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to achieving stimulated C-peptide level ≥0.3 ng/mL
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
Number of subjects achieving stimulated C-peptide level ≥0.3 ng/mL
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
Number of subjects experiencing hypoglycemia unawareness or severe hypoglycemic events
Time Frame: Within one year after CRG-002 transplantation
Within one year after CRG-002 transplantation
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)
Within one year after CRG-002 transplantation
Number of subjects achieving HbA1c <6.5%
Time Frame: Within one year after CRG-002 transplantation
Count the number of subjects achieving glycated hemoglobin (HbA1c) less than 6.5%, and record the time to first achievement of this target.
Within one year after CRG-002 transplantation
68Ga-exendin-4 PET/MRI imaging assessment
Time Frame: Within one year after CRG-002 transplantation
Only for subjects receiving portal vein infusion and achieved insulin independence. Assess total distribution volume of intrahepatic grafts, total number of islet hotspots, and sum volume of individual graft lesions. Subjects with rectus sheath transplantation or without insulin-independence will not undergo this imaging examination.
Within one year after CRG-002 transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celregen Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRG002SEIIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidential Information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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