Diabete MellitusPhase 1/2NCT07581197
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
A Phase 1/2 study testing Allogeneic pancreatic endocrine cell clusters in people with Diabete Mellitus and Diabete Type 1, run by Seraxis.
Trial summary
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabete Mellitus, Diabete Type 1
- What is being tested?
- Allogeneic pancreatic endocrine cell clusters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2029
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 to 65 years with a clinical history of T1D
- Diagnosis of T1D at <40 years of age
- Insulin dependence for ≥5 years at pre-screening
- Recurrent severe hypoglycemia
- Willingness to use continuous glucose monitoring
Who cannot join
- Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
- Weight loss medication(s) within 3 months of Screening
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)
This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.
- Conditions
- Diabete Mellitus, Diabete Type 1
- Being tested
- Allogeneic pancreatic endocrine cell clusters
- Keywords
- Severe hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic pancreatic endocrine cell clustersBiological
Allogeneic pancreatic endocrine cell clusters
| Study group | Role | What they receive |
|---|---|---|
| SR-02 allogeneic pancreatic endocrine cell clusters | Experimental | Not described Receives: Biological: Allogeneic pancreatic endocrine cell clusters |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0.
Safety variables include the percentage, severity, and relatedness of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the SR-02 implant to Day 365.
Measured: Day 35 to Day 365
Change in C-peptide secretion from baseline.
Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.
Measured: Enrollment to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seraxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581197
- Sponsor's protocol ID
- SR-02-0201
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)
- ClinicalTrials.gov ID
- NCT07581197
- Acronym / sponsor ID
- SR-02-0201
- Conditions
- Diabete Mellitus, Diabete Type 1
- Keywords
- Severe hypoglycemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- SeraxisIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 12 May 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 will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SR-02 allogeneic pancreatic endocrine cell clusters | Experimental | Biological: Allogeneic pancreatic endocrine cell clusters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult 18 to 65 years with a clinical history of T1D
- Diagnosis of T1D at <40 years of age
- Insulin dependence for ≥5 years at pre-screening
- Recurrent severe hypoglycemia
- Willingness to use continuous glucose monitoring
Key exclusion criteria (3 listed)
- Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
- Weight loss medication(s) within 3 months of Screening
- Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| Allogeneic pancreatic endocrine cell clustersAllogeneic pancreatic endocrine cell clusters | Biological | SR-02 allogeneic pancreatic endocrine cell clusters |
Primary outcome
To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0.
Time frame: Day 35 to Day 365
Safety variables include the percentage, severity, and relatedness of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the SR-02 implant to Day 365.
Change in C-peptide secretion from baseline.
Time frame: Enrollment to Day 365
Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic pancreatic endocrine cell clusters in people with Diabete Mellitus and Diabete Type 1, run by Seraxis.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Director of Clinical Operations (240-780- 8064, info@seraxis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0. (time frame: Day 35 to Day 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.