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Not yet recruitingNCT07581197Updated Oct 19, 2026

Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes

A Phase 1/2 interventional study of Allogeneic pancreatic endocrine cell clusters in Diabete Mellitus and Diabete Type 1, sponsored by Seraxis. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Seraxis · Phase 1/2, Interventional, and Treatment

Updated Oct 19, 2026Study contact changedGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabete Mellitus
  • Diabete Type 1

Keywords

  • Severe hypoglycemia
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 9 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Seraxis is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria

  • 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

  • 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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    SR-02 allogeneic pancreatic endocrine cell clusters

    Biological: Allogeneic pancreatic endocrine cell clusters

Interventions

  • BiologicalAllogeneic pancreatic endocrine cell clusters

    Allogeneic pancreatic endocrine cell clusters

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 35 to Day 365

  2. Change in C-peptide secretion from baseline.

    Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.

    Time frame: Enrollment to Day 365

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

Of 40 phase 1/2 interventional studies under Diabetes Mellitus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 60. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2026
First posted
May 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Nov 2028
CompletionEst.
Nov 2029
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact's phone or email changed: •••8681→•••8064. See the current contact
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Contact Study contact's phone or email changed: •••8681→•••8064. See the current contact

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07581197
Lead sponsor
Seraxis
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2028 (estimated)
Completion
Nov 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Director of Clinical Operations
Contact
info@seraxis.com
240-780- 8064

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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