T1DM - Type 1 Diabetes MellitusEarly Phase 1NCT07503028
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
A Early Phase 1 study testing CRG002 in people with T1DM - Type 1 Diabetes Mellitus and Pancreatogenic Diabetes Mellitus, run by Celregen Therapeutics at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T1DM - Type 1 Diabetes Mellitus, Pancreatogenic Diabetes Mellitus
- What is being tested?
- CRG002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to 18 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Agree to use the study-designated monitoring device.
- Psychologically stable.
- Full legal capacity.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medicaluniversity
Hefei, Anhui, 230022
About this study
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.
- Being tested
- CRG002
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRG002Drug
Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | CRG002 Receives: Drug: CRG002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by number of adverse events accoridng to CTCAE v 6.0
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)
Measured: Within one year after CRG-002 transplantation
Secondary outcomes (7)
Daily insulin dosage of subjects
Measured: Within one year after CRG-002 transplantation
Time to subjects achieving insulin independence.
Measured: Within one year after CRG-002 transplantation
Numbers of subjects achieving insulin independence.
Measured: Within one year after CRG-002 transplantation
Changes in blood glucose levels
Changes in blood glucose levels in subjects after CRG-002 transplantation
Measured: Within one year after CRG-002 transplantation
Changes in Time in range of glucose
Measured: Within one year after CRG-002 transplantation
Time to achieving HbA1c <7.0% (if baseline HbA1c ≥7.0%) or a ≥1% reduction from baseline.
Measured: 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%).
Measured: Within one year after CRG-002 transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start17 Oct 2025
- Primary completion18 Jan 2028 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for T1DM - Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celregen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503028
- Sponsor's protocol ID
- CRG002SEIIT
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential Information
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.
PubMed 32641151Gregory 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):741-760. doi: 10.1016/S2213-8587(22)00218-2. Epub 2022 Sep 13.
PubMed 36113507Holt 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.
PubMed 34590174
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07503028
- Acronym / sponsor ID
- CRG002SEIIT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Celregen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 18 Jan 2028 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: CRG002CRG002 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRG002Intraportal infusion or Implantation underneath the abdominal anterior rectus sheat | Drug | Experimental group |
Primary outcome
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)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 32641151Chen 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.
- Background: PubMed 36113507Gregory 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):741-760. doi: 10.1016/S2213-8587(22)00218-2. Epub 2022 Sep 13.
- Background: PubMed 34590174Holt 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.
- Individual participant dataSharing planned: No. Confidential Information
Related trials for T1DM - Type 1 Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
Not yet recruitingPhase 2
JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
T1DM - Type 1 Diabetes Mellitus
RecruitingObservational study
Environmental Determinants of Type 1 Diabetes Risk
Type 1 Diabetes Mellitus (T1DM), Healthy Control
Not yet recruiting
Pre-Exercise Whey and Pea Protein in Adolescents With Type 1 Diabetes
T1D, T1DM
Recruiting
Drawing and Writing Activities in Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus (T1DM), Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CRG002 in people with T1DM - Type 1 Diabetes Mellitus and Pancreatogenic Diabetes Mellitus, run by Celregen Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by number of adverse events accoridng to CTCAE v 6.0 (time frame: Within one year after CRG-002 transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503028, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.